Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

NCT01985334 | Completed Phase 4 Results

• 1 other identifier: CQVA149A3401
• Study Type: interventional
• Target: 4,389
• Locations: 21 countries
• Sites: 523

Brief Summary

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Conditions

COPD

Keywords

Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149

Outcome Measures

Primary Outcomes (8)

• Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

  Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

  Week 12 (Visit 4)

• Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval

  Week 12 (Visit 4)

• Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

  Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

  Week 12 (Visit 4)

• Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.

  Week 12 (Visit 4)

• Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)

  Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

  Day 1 (baseline) and week 12

• Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

  Day 1 (baseline) and week 12

• Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC

  Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

  Day 1 (baseline) and week 12

• Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.

  Day 1 (baseline) and week 12

Secondary Outcomes (8)

• Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  12 Weeks

• Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)

  Day 1 (baseline) and week 12

• Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.

  12 Weeks

• Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC

  Day 1 (baseline) and week 12

• Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC

  Day 1 (baseline) and Week 12

Study Arms (8)

A1 (any SABA and/or SAMA)

EXPERIMENTAL

Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) during 90 days of treatment

Drug: Glycopyrronium; Drug: SABA; Drug: SAMA

A2 (glycopyrronium)

EXPERIMENTAL

Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Drug: Glycopyrronium; Drug: SABA; Drug: LABA; Drug: SAMA

B1 (any LAMA or LABA and mMRC=1)

EXPERIMENTAL

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA

Drug: LABA; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: LAMA; Drug: ICS

B2 (glycopyrronium and mMRC=1)

EXPERIMENTAL

Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)

Drug: LABA; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: LAMA

C1 (any LABA and ICS)

EXPERIMENTAL

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC

Drug: LABA; Drug: ICS

C2 (indacaterol/glycopyrronium)

EXPERIMENTAL

Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)

Drug: LABA; Drug: ICS

D1 (any LAMA or LABA and mMRC>1)

EXPERIMENTAL

Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA

Drug: LAMA

D2 (indacaterol/glycopyrronium and mMRC>1)

EXPERIMENTAL

Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).

Drug: LAMA

Interventions

Glycopyrronium DRUG

Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day

Also known as: glycopyrronium bromide

A1 (any SABA and/or SAMA); A2 (glycopyrronium)

SABA DRUG

Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy

A1 (any SABA and/or SAMA); A2 (glycopyrronium)

LABA DRUG

Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy

A2 (glycopyrronium); B1 (any LAMA or LABA and mMRC=1); B2 (glycopyrronium and mMRC=1); C1 (any LABA and ICS); C2 (indacaterol/glycopyrronium)

Indacaterol maleate and glycopyrronium bromide DRUG

Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day

B1 (any LAMA or LABA and mMRC=1); B2 (glycopyrronium and mMRC=1)

LAMA DRUG

Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy

B1 (any LAMA or LABA and mMRC=1); B2 (glycopyrronium and mMRC=1); D1 (any LAMA or LABA and mMRC>1); D2 (indacaterol/glycopyrronium and mMRC>1)

SAMA DRUG

Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy

A1 (any SABA and/or SAMA); A2 (glycopyrronium)

ICS DRUG

Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy

B1 (any LAMA or LABA and mMRC=1); C1 (any LABA and ICS); C2 (indacaterol/glycopyrronium)

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults aged ≥ 40 years
• Patients with moderate COPD according to the GOLD criteria 2013
• Current or ex-smokers who have a smoking history of at least 10 pack years
• Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and \<80% of the predicted normal value and a post-bronchodilator FEV1/FVC \<0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol
• Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: \*Any SABA monotherapy (such as, but not limited to, salbutamol) \*Any SAMA monotherapy (such as, but not limited to, ipratropium) \*Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) \*Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) \*Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) \*Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
• Patients with an mMRC score ≥1 at Visit 1.

You may not qualify if:

• Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.
• Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
• Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
• Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).
• A documented history of \>1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.
• History of resting QTc (Fridericia preferred, but Bazett acceptable) \>450 msec (male) or \>460 msec (female) within five years before Visit 1.
• Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.
• Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.
• Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
• Patients with a body mass index (BMI) of more than 40 kg/m2.
• Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (542)

Novartis Investigative Site

Amstetten, 3300, Austria

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Feldkirch, 6800, Austria

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Hallein, 5400, Austria

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Kirchdorf an der Krems, 4560, Austria

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Leoben, 8700, Austria

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Linz, 4020, Austria

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Perg, 4320, Austria

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Salzburg, 5020, Austria

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Wels, 4600, Austria

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Gosselies, BEL, 6041, Belgium

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Gozée, BEL, 6534, Belgium

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Zichem, BEL, 3271, Belgium

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Antwerp, 2060, Belgium

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Balen, 2490, Belgium

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Braine-l'Alleud, 1420, Belgium

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Erpent, 5100, Belgium

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Éghezée, 5310, Belgium

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Geraardsbergen, 9500, Belgium

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Gilly, 6060, Belgium

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Halen, 3545, Belgium

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Hasselt, 3500, Belgium

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Heusy, 4802, Belgium

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Ieper, 8900, Belgium

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Knokke-Heist, 8300, Belgium

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Lebbeke, 9280, Belgium

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Liège, 4000, Belgium

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Maaseik, 3680, Belgium

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Malmedy, 4960, Belgium

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Mechelen, 2800, Belgium

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Melsbroek, 1820, Belgium

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Merksem, 2170, Belgium

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Montegnée, 4420, Belgium

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Natoye, 5360, Belgium

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Paal-Beringen, 3583, Belgium

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Ronse, 9600, Belgium

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Saint-Médard, 6887, Belgium

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Seraing, 4100, Belgium

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Tournai, 7500, Belgium

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Verviers, 4800, Belgium

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Vilvoorde, 1800, Belgium

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Zottegem, 9620, Belgium

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Boskovice, Czech Republic, 680 01, Czechia

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Brandýs nad Labem, Czech Republic, 25001, Czechia

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Brno-Královo Pole, Czech Republic, 61200, Czechia

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Cvikov, Czech Republic, 471 54, Czechia

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Havlíčkův Brod, Czech Republic, 580 01, Czechia

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Jirkov, Czech Republic, 43111, Czechia

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Kuřim, Czech Republic, 66434, Czechia

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Liberec, Czech Republic, 460 01, Czechia

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Lovosice, Czech Republic, 410 02, Czechia

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Neratovice, Czech Republic, 27711, Czechia

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Ostrava, Czech Republic, 708 68, Czechia

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Pardubice, Czech Republic, 530 09, Czechia

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Pilsen, Czech Republic, 33011, Czechia

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Pilsen, Czech Republic, 331 01, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 108 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 130 00, Czechia

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Prague, Czech Republic, 140 46, Czechia

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Prague, Czech Republic, 142 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 14800, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 163 00, Czechia

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Novartis Investigative Site

Prague, Czech Republic, 19000, Czechia

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Rokycany, Czech Republic, 337 22, Czechia

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Rudná, Czech Republic, 25219, Czechia

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Teplice, Czech Republic, 415 01, Czechia

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Třebíč, Czech Republic, 674 01, Czechia

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Varnsdorf, Czech Republic, 40747, Czechia

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Znojmo, Czech Republic, 672 01, Czechia

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Žatec, Czech Republic, 438 01, Czechia

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Prague, 182 00, Czechia

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Alleroed, 3450, Denmark

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Greve, 2670, Denmark

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Haslev, 4690, Denmark

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Søborg, 2860, Denmark

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Værløse, 3500, Denmark

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Paide, 72714, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 10617, Estonia

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Tallinn, 13419, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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Tours, Indre Et Loire, 37044, France

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Briis-sous-Forges, 91640, France

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Chamalières, 63400, France

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Châtellerault, 86100, France

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Forbach, 57600, France

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L'Aigle, 61305, France

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La Bouëxière, 35340, France

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Marseille, 13003, France

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Montpellier, 34080, France

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Mûrs-Erigné, 49610, France

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Nice, 06000, France

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Saint-Jean-de-Luz, 64500, France

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Saint-Laurent-du-Var, 06721, France

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Saint-Pierre, 97448, France

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Strasbourg, 67000, France

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Toulon, 83000, France

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Hanover, Lower Saxony, 30159, Germany

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Peine, Lower Saxony, 31224, Germany

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Koblenz, North Rhine-Westphalia, 56068, Germany

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Warendorf, North Rhine-Westphalia, 48231, Germany

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Essen, Rhineland-Palatinate, 45127, Germany

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Cottbus, Saxony, 03050, Germany

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Geesthacht, Schleswig-Holstein, 12502, Germany

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Annaberg-Buchholz, 09456, Germany

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Auerbach, 08209, Germany

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Augsburg, 86150, Germany

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Bad Neustadt an der Saale, 97616, Germany

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Bad Salzuflen, 32105, Germany

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Bad Wörishofen, 86825, Germany

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Bamberg, 96049, Germany

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Bensheim, 64625, Germany

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Berlin, 10117, Germany

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Berlin, 10119, Germany

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Berlin, 10367, Germany

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Berlin, 10625, Germany

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Berlin, 10629, Germany

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Novartis Investigative Site

Berlin, 10717, Germany

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Berlin, 10787, Germany

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Berlin, 12099, Germany

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Berlin, 12157, Germany

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Berlin, 12159, Germany

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Berlin, 12165, Germany

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Berlin, 12203, Germany

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Berlin, 12627, Germany

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Berlin, 12687, Germany

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Berlin, 13057, Germany

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Berlin, 13086, Germany

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Berlin, 13156, Germany

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Berlin, 13187, Germany

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Berlin, 13507, Germany

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Berlin, 14059, Germany

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Berlin, D-12165, Germany

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Bielefeld, 33617, Germany

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Bochum, 44787, Germany

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Bonn, 53119, Germany

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Bonn, 53123, Germany

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Bottrop, 46240, Germany

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Bruchsal, 76646, Germany

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Burgwedel, 30938, Germany

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Cologne, 50668, Germany

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Cologne, 50937, Germany

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Cologne, 51069, Germany

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Cologne, 51605, Germany

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Daaden, 57567, Germany

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Dachau, 85221, Germany

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Deggendorf, 94469, Germany

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Deggingen, 73328, Germany

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Delitzsch, 04509, Germany

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Dortmund, 44263, Germany

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Dresden, 01069, Germany

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Dresden, 01129, Germany

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Düren, 52349, Germany

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Düsseldorf, 40211, Germany

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Düsseldorf, 40489, Germany

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Eisenach, 99817, Germany

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Elsterwerda, 04910, Germany

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Erlangen, 91054, Germany

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Essen, 45138, Germany

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Essen, 45147, Germany

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Novartis Investigative Site

Essen, 45276, Germany

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Essen, 45277, Germany

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Novartis Investigative Site

Essen, 45355, Germany

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Essen, 45359, Germany

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Föhren, 54343, Germany

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Frankenberg (Eder), 35066, Germany

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Frankfurt, 60389, Germany

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Frankfurt am Main, 60313, Germany

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Freiburg im Breisgau, 79104, Germany

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Freudenberg, 57258, Germany

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Fürstenwalde, 15517, Germany

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Garmisch-Partenkirchen, 82467, Germany

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Gauting, 82131, Germany

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Giessen, 35390, Germany

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Gifhorn, 38518, Germany

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Goch, 47574, Germany

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Görlitz, 02826, Germany

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Gummersbach, 51343, Germany

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Novartis Investigative Site

Gütersloh, 33330, Germany

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Novartis Investigative Site

Hagen, 58089, Germany

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Novartis Investigative Site

Halberstadt, 38820, Germany

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Novartis Investigative Site

Halle, 06108, Germany

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Hamburg, 20253, Germany

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Novartis Investigative Site

Hamburg, 20354, Germany

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Novartis Investigative Site

Hamburg, 20357, Germany

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Novartis Investigative Site

Hamburg, 22143, Germany

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Novartis Investigative Site

Hamburg, 22299, Germany

Location

Novartis Investigative Site

Hamburg, 22335, Germany

Location

Novartis Investigative Site

Hamburg, 22527, Germany

Location

Novartis Investigative Site

Hanover, 30163, Germany

Location

Novartis Investigative Site

Hanover, 30173, Germany

Location

Novartis Investigative Site

Hanover, 30419, Germany

Location

Novartis Investigative Site

Heidelberg, 69117, Germany

Location

Novartis Investigative Site

Hettstedt, 06333, Germany

Location

Novartis Investigative Site

Hildesheim, 31134, Germany

Location

Novartis Investigative Site

Hoyerswerda, 02977, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Jerichow, 39319, Germany

Location

Novartis Investigative Site

Kamen, 59174, Germany

Location

Novartis Investigative Site

Karlsruhe, 76199, Germany

Location

Novartis Investigative Site

Kassel, 34117, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Kleve, 47533, Germany

Location

Novartis Investigative Site

Köthen, 06366, Germany

Location

Novartis Investigative Site

Landau-Pfalz, 76829, Germany

Location

Novartis Investigative Site

Landsberg, 86899, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Leipzig, 04109, Germany

Location

Novartis Investigative Site

Leipzig, 04207, Germany

Location

Novartis Investigative Site

Leipzig, 04275, Germany

Location

Novartis Investigative Site

Leipzig, 04357, Germany

Location

Novartis Investigative Site

Leonberg, 71229, Germany

Location

Novartis Investigative Site

Leverkusen, 51379, Germany

Location

Novartis Investigative Site

Limburgerhof, 67117, Germany

Location

Novartis Investigative Site

Löhne, 32584, Germany

Location

Novartis Investigative Site

Ludwigsburg, 71640, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67061, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67067, Germany

Location

Novartis Investigative Site

Lübeck, 23554, Germany

Location

Novartis Investigative Site

Lüdenscheid, 58507, Germany

Location

Novartis Investigative Site

Magdeburg, 39112, Germany

Location

Novartis Investigative Site

Marburg, 35033, Germany

Location

Novartis Investigative Site

Marburg, 35037, Germany

Location

Novartis Investigative Site

Marburg, D-35037, Germany

Location

Novartis Investigative Site

Mayen, 56727, Germany

Location

Novartis Investigative Site

Meine, 38527, Germany

Location

Novartis Investigative Site

Meissen, 01662, Germany

Location

Novartis Investigative Site

Menden, 58706, Germany

Location

Novartis Investigative Site

Minden, 32423, Germany

Location

Novartis Investigative Site

Mittweida, 09648, Germany

Location

Novartis Investigative Site

Mülheim, 45468, Germany

Location

Novartis Investigative Site

München, 80335, Germany

Location

Novartis Investigative Site

München, 80802, Germany

Location

Novartis Investigative Site

Münnerstadt, 97702, Germany

Location

Novartis Investigative Site

Neu-Isenburg, 63263, Germany

Location

Novartis Investigative Site

Neu-Ulm, 89231, Germany

Location

Novartis Investigative Site

Neunkirchen, 66539, Germany

Location

Novartis Investigative Site

Neuss, 41462, Germany

Location

Novartis Investigative Site

Neuwied, 56564, Germany

Location

Novartis Investigative Site

Northeim, 37154, Germany

Location

Novartis Investigative Site

Nuremberg, 90443, Germany

Location

Novartis Investigative Site

Nuremberg, 90478, Germany

Location

Novartis Investigative Site

Obermichelbach, 90587, Germany

Location

Novartis Investigative Site

Oschatz, 04758, Germany

Location

Novartis Investigative Site

Oschersleben, 39387, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Papenburg, 26871, Germany

Location

Novartis Investigative Site

Passau, 94032, Germany

Location

Novartis Investigative Site

Plauen, 08523, Germany

Location

Novartis Investigative Site

Potsdam, 14467, Germany

Location

Novartis Investigative Site

Potsdam, 14469, Germany

Location

Novartis Investigative Site

Prien A. Chiemsee, 83209, Germany

Location

Novartis Investigative Site

Radebeul, 01445, Germany

Location

Novartis Investigative Site

Ratingen, 40878, Germany

Location

Novartis Investigative Site

Raubach, 56316, Germany

Location

Novartis Investigative Site

Reinfeld, 23858, Germany

Location

Novartis Investigative Site

Rheine, 48431, Germany

Location

Novartis Investigative Site

Rodenbach, 67688, Germany

Location

Novartis Investigative Site

Roth, 91154, Germany

Location

Novartis Investigative Site

Rüdersdorf, 15562, Germany

Location

Novartis Investigative Site

Rüsselsheim am Main, 65428, Germany

Location

Novartis Investigative Site

Saalfeld, 07318, Germany

Location

Novartis Investigative Site

Saarbrücken, 66111, Germany

Location

Novartis Investigative Site

Schleswig, 24837, Germany

Location

Novartis Investigative Site

Schwabach, 91126, Germany

Location

Novartis Investigative Site

Schwedt, 16303, Germany

Location

Novartis Investigative Site

Schwerin, 19055, Germany

Location

Novartis Investigative Site

Schwetzingen, 68723, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Sinsheim, 74889, Germany

Location

Novartis Investigative Site

Solingen, 42651, Germany

Location

Novartis Investigative Site

Solingen, 42665, Germany

Location

Novartis Investigative Site

Solingen, 42697, Germany

Location

Novartis Investigative Site

Sonneberg, 96515, Germany

Location

Novartis Investigative Site

Strausberg, 15344, Germany

Location

Novartis Investigative Site

Teuchern, 06682, Germany

Location

Novartis Investigative Site

Ulm, 89073, Germany

Location

Novartis Investigative Site

Wardenburg, 26203, Germany

Location

Novartis Investigative Site

Weilheim, 82362, Germany

Location

Novartis Investigative Site

Welzheim, 73642, Germany

Location

Novartis Investigative Site

Westerkappeln, 49492, Germany

Location

Novartis Investigative Site

Wiesloch, 69168, Germany

Location

Novartis Investigative Site

Wissen, 57537, Germany

Location

Novartis Investigative Site

Witten, 58452, Germany

Location

Novartis Investigative Site

Wolfsburg, 38448, Germany

Location

Novartis Investigative Site

Wöllstein, 55597, Germany

Location

Novartis Investigative Site

Zerbst, 39261, Germany

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 564 29, Greece

Location

Novartis Investigative Site

Serres, GR 62 100, Greece

Location

Novartis Investigative Site

Győr, HUN, 9024, Hungary

Location

Novartis Investigative Site

Százhalombatta, HUN, 2440, Hungary

Location

Novartis Investigative Site

Cegléd, 2700, Hungary

Location

Novartis Investigative Site

Debrecen, 4026, Hungary

Location

Novartis Investigative Site

Hatvan, 3000, Hungary

Location

Novartis Investigative Site

Komárom, 2900, Hungary

Location

Novartis Investigative Site

Makó, 6900, Hungary

Location

Novartis Investigative Site

Mátészalka, 4700, Hungary

Location

Novartis Investigative Site

Pécs, 7624, Hungary

Location

Novartis Investigative Site

Pécs, 7635, Hungary

Location

Novartis Investigative Site

Szeged, 6722, Hungary

Location

Novartis Investigative Site

Tatabánya, 2800, Hungary

Location

Novartis Investigative Site

Törökbálint, 2045, Hungary

Location

Novartis Investigative Site

County Limerick, V94 F858, Ireland

Location

Novartis Investigative Site

Dublin, 24, Ireland

Location

Novartis Investigative Site

Dublin, DUBLIN 8, Ireland

Location

Novartis Investigative Site

Dublin, Ireland

Location

Novartis Investigative Site

Ancona, AN, 60128, Italy

Location

Novartis Investigative Site

Avellino, AV, 83100, Italy

Location

Novartis Investigative Site

Bari, BA, 70123, Italy

Location

Novartis Investigative Site

Bari, BA, 70124, Italy

Location

Novartis Investigative Site

Terlizzi, BA, 70038, Italy

Location

Novartis Investigative Site

Triggiano, BA, 70019, Italy

Location

Novartis Investigative Site

Romano di Lombardia, BG, 24058, Italy

Location

Novartis Investigative Site

Feltre, BL, 32032, Italy

Location

Novartis Investigative Site

Telese Terme, BN, 82037, Italy

Location

Novartis Investigative Site

San Pietro Vernotico, BR, 72027, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Campobasso, CB, 86100, Italy

Location

Novartis Investigative Site

Marcianise, CE, 81025, Italy

Location

Novartis Investigative Site

Caltanissetta, CL, 93100, Italy

Location

Novartis Investigative Site

Saluzzo, CN, 12037, Italy

Location

Novartis Investigative Site

Catania, CT, 95100, Italy

Location

Novartis Investigative Site

Catania, CT, 95122, Italy

Location

Novartis Investigative Site

Catania, CT, 95126, Italy

Location

Novartis Investigative Site

Forlì, FC, 47100, Italy

Location

Novartis Investigative Site

Foggia, FG, 71100, Italy

Location

Novartis Investigative Site

San Severo, FG, 71016, Italy

Location

Novartis Investigative Site

Florence, FI, 50122, Italy

Location

Novartis Investigative Site

Florence, FI, 50134, Italy

Location

Novartis Investigative Site

Genova, GE, 16100, Italy

Location

Novartis Investigative Site

Livorno, LI, 57124, Italy

Location

Novartis Investigative Site

Lodi, LO, 26900, Italy

Location

Novartis Investigative Site

Lido di Camaiore, LU, 55041, Italy

Location

Novartis Investigative Site

Monza, MB, 20900, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Nuoro, NU, 08100, Italy

Location

Novartis Investigative Site

Palermo, PA, 90127, Italy

Location

Novartis Investigative Site

Palermo, PA, 90146, Italy

Location

Novartis Investigative Site

Piacenza, PC, 29100, Italy

Location

Novartis Investigative Site

Cittadella, PD, 35013, Italy

Location

Novartis Investigative Site

Pisa, PI, 56124, Italy

Location

Novartis Investigative Site

Pordenone, PN, 33170, Italy

Location

Novartis Investigative Site

Voghera, PV, 27058, Italy

Location

Novartis Investigative Site

Roma, RM, 00128, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Roma, RM, 00163, Italy

Location

Novartis Investigative Site

Roma, RM, 00189, Italy

Location

Novartis Investigative Site

Riccione, RN, 47838, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Sondalo, SO, 23035, Italy

Location

Novartis Investigative Site

Sassari, SS, 07100, Italy

Location

Novartis Investigative Site

Orbassano, TO, 10043, Italy

Location

Novartis Investigative Site

Terni, TR, 05100, Italy

Location

Novartis Investigative Site

Montebelluna, TV, 31044, Italy

Location

Novartis Investigative Site

Vittorio Veneto, TV, 31029, Italy

Location

Novartis Investigative Site

Busto Arsizio, VA, 21052, Italy

Location

Novartis Investigative Site

Arzignano, VI, 36071, Italy

Location

Novartis Investigative Site

Vicenza, VI, 36100, Italy

Location

Novartis Investigative Site

Bussolengo, VR, 37012, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Torino, 10149, Italy

Location

Novartis Investigative Site

Balvi, LVA, 4501, Latvia

Location

Novartis Investigative Site

Jūrmala, LVA, LV-2015, Latvia

Location

Novartis Investigative Site

Riga, LV, 1011, Latvia

Location

Novartis Investigative Site

Riga, LV, LV-1038, Latvia

Location

Novartis Investigative Site

Daugavpils, LV-5401, Latvia

Location

Novartis Investigative Site

Riga, LV 1002, Latvia

Location

Novartis Investigative Site

Riga, LV-1001, Latvia

Location

Novartis Investigative Site

Vilnius, LTU, LT-10207, Lithuania

Location

Novartis Investigative Site

Kaunas, LT, LT-50128, Lithuania

Location

Novartis Investigative Site

Vilnius, LT, 01117, Lithuania

Location

Novartis Investigative Site

Alytus, LT-62114, Lithuania

Location

Novartis Investigative Site

Kaunas, 3007, Lithuania

Location

Novartis Investigative Site

Klaipėda, LT-92288, Lithuania

Location

Novartis Investigative Site

Utena, LT-28151, Lithuania

Location

Novartis Investigative Site

Vilnius, 06122, Lithuania

Location

Novartis Investigative Site

Vilnius, LT-08661, Lithuania

Location

Novartis Investigative Site

Førde, 6800, Norway

Location

Novartis Investigative Site

Kløfta, 2040, Norway

Location

Novartis Investigative Site

Lierskogen, 3420, Norway

Location

Novartis Investigative Site

Oslo, 0190, Norway

Location

Novartis Investigative Site

Oslo, 0953, Norway

Location

Novartis Investigative Site

Skedsmokorset, 2020, Norway

Location

Novartis Investigative Site

Skien, 3734, Norway

Location

Novartis Investigative Site

Stavanger, 4005, Norway

Location

Novartis Investigative Site

Tananger, 4056, Norway

Location

Novartis Investigative Site

Bialystok, 15-044, Poland

Location

Novartis Investigative Site

Krakow, 31-024, Poland

Location

Novartis Investigative Site

Nowy Dwór Mazowiecki, 05-100, Poland

Location

Novartis Investigative Site

Ostrów Wielkopolski, 63-400, Poland

Location

Novartis Investigative Site

Piła, 64-920, Poland

Location

Novartis Investigative Site

Sopot, 81-741, Poland

Location

Novartis Investigative Site

Warsaw, 01-138, Poland

Location

Novartis Investigative Site

Wroclaw, 51-162, Poland

Location

Novartis Investigative Site

Aveiro, 3814-501, Portugal

Location

Novartis Investigative Site

Barcelos, 4754-909, Portugal

Location

Novartis Investigative Site

Coimbra, 3041-853, Portugal

Location

Novartis Investigative Site

Guimarães, 4835-044, Portugal

Location

Novartis Investigative Site

Lisbon, 1169-024, Portugal

Location

Novartis Investigative Site

Lisbon, 1349-019, Portugal

Location

Novartis Investigative Site

Porto, 4200 319, Portugal

Location

Novartis Investigative Site

Vila Franca de Xira, 2600-009, Portugal

Location

Novartis Investigative Site

Vila Nova de Gaia, 440-230, Portugal

Location

Novartis Investigative Site

Bucharest, District 3, 030303, Romania

Location

Novartis Investigative Site

Iași, Jud. Iasi, 700115, Romania

Location

Novartis Investigative Site

Bacau, 600252, Romania

Location

Novartis Investigative Site

Bragadiru, 077025, Romania

Location

Novartis Investigative Site

Constanța, 900591, Romania

Location

Novartis Investigative Site

Râmnicu Vâlcea, 240564, Romania

Location

Novartis Investigative Site

Suceava, 720284, Romania

Location

Novartis Investigative Site

Timișoara, 300736, Romania

Location

Novartis Investigative Site

Chelyabinsk, 454021, Russia

Location

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Kemerovo, 650029, Russia

Location

Novartis Investigative Site

Moscow, 101990, Russia

Location

Novartis Investigative Site

Moscow, 125315, Russia

Location

Novartis Investigative Site

N.Novgorod, 603126, Russia

Location

Novartis Investigative Site

Novosibirsk, 630099, Russia

Location

Novartis Investigative Site

Ryazan, 390026, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194354, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197022, Russia

Location

Novartis Investigative Site

Saratov, 410012, Russia

Location

Novartis Investigative Site

Smolensk, 214019, Russia

Location

Novartis Investigative Site

Tomsk, 634050, Russia

Location

Novartis Investigative Site

Ufa, 450000, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Bardejov, Slovak Republic, 085 01, Slovakia

Location

Novartis Investigative Site

Bojnice, Slovak Republic, 972 01, Slovakia

Location

Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

Location

Novartis Investigative Site

Námestovo, Slovensko, 02901, Slovakia

Location

Novartis Investigative Site

Kráľovský Chlmec, 077 01, Slovakia

Location

Novartis Investigative Site

Levice, 034 01, Slovakia

Location

Novartis Investigative Site

Poprad, 058 01, Slovakia

Location

Novartis Investigative Site

Prešov, 080 01, Slovakia

Location

Novartis Investigative Site

Prešov, 08001, Slovakia

Location

Novartis Investigative Site

Šaľa, 927 01, Slovakia

Location

Novartis Investigative Site

Štúrovo, 943 11, Slovakia

Location

Novartis Investigative Site

Trnava, 917 75, Slovakia

Location

Novartis Investigative Site

Vráble, 95201, Slovakia

Location

Novartis Investigative Site

Golnik, 4204, Slovenia

Location

Novartis Investigative Site

Kranj, 4000, Slovenia

Location

Novartis Investigative Site

Maribor, 2000, Slovenia

Location

Novartis Investigative Site

Murska Sobota, 9000, Slovenia

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Marbella, Andalusia, 29600, Spain

Location

Novartis Investigative Site

Marbella, Andalusia, 29603, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Mallorca, Balearic Islands, 07198, Spain

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Novartis Investigative Site

Badalona, Barcelona, 08917, Spain

Location

Novartis Investigative Site

Centelles, Barcelona, 08540, Spain

Location

Novartis Investigative Site

Mataró, Barcelona, 08303, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Sant Joan Despí, Barcelona, 08970, Spain

Location

Novartis Investigative Site

Vic, Barcelona, 08500, Spain

Location

Novartis Investigative Site

Ponferrada, Castille and León, 24400, Spain

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Canet de Mar, Catalonia, 08360, Spain

Location

Novartis Investigative Site

Sant Boi de Llobregat, Catalonia, 08830, Spain

Location

Novartis Investigative Site

Vic, Catalonia, 08500, Spain

Location

Novartis Investigative Site

Cáceres, Extremadura, 10003, Spain

Location

Novartis Investigative Site

Mérida, Extremadura, 06800, Spain

Location

Novartis Investigative Site

Motril, Granada, 18600, Spain

Location

Novartis Investigative Site

Valdemoro, Madrid, 28342, Spain

Location

Novartis Investigative Site

Madrid, Madrid, Communidad de, 28022, Spain

Location

Novartis Investigative Site

Móstoles, Madrid, Communidad de, 28933, Spain

Location

Novartis Investigative Site

Alzira, Valencia, 46600, Spain

Location

Novartis Investigative Site

Benidorm, Valencia, 03501, Spain

Location

Novartis Investigative Site

Port de Sagunt, Valencia, 46520, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46015, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46019, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Santiago de Compostela, 15706, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Gothenburg, 413 46, Sweden

Location

Novartis Investigative Site

Gustavsberg, 134 44, Sweden

Location

Novartis Investigative Site

Helsingborg, 252 25, Sweden

Location

Novartis Investigative Site

Höllviken, 236 32, Sweden

Location

Novartis Investigative Site

Kungshamn, 456 31, Sweden

Location

Novartis Investigative Site

Limhamn, 216 43, Sweden

Location

Novartis Investigative Site

Lund, 222 22, Sweden

Location

Novartis Investigative Site

Råå, 252 70, Sweden

Location

Novartis Investigative Site

Umeå, 907 40, Sweden

Location

Novartis Investigative Site

Västra Frölunda, 421 44, Sweden

Location

Novartis Investigative Site

Linköping, Östergötland County, 587 58, Sweden

Location

Novartis Investigative Site

Aylesbury, Bucks, HP22 5LB, United Kingdom

Location

Novartis Investigative Site

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Novartis Investigative Site

Liskeard, Cornwall, PL14 3XA, United Kingdom

Location

Novartis Investigative Site

Penzance, Cornwall, TR18 AJH, United Kingdom

Location

Novartis Investigative Site

Redruth, Cornwall, United Kingdom

Location

Novartis Investigative Site

St Austell, Cornwall, PL26 7RL, United Kingdom

Location

Novartis Investigative Site

Torpoint, Cornwall, PL11 2TB, United Kingdom

Location

Novartis Investigative Site

Bath, England, BA2 3HT, United Kingdom

Location

Novartis Investigative Site

Havant, Hampshire, PO9 1DQ, United Kingdom

Location

Novartis Investigative Site

Burbage, Leicester, LE10 2SE, United Kingdom

Location

Novartis Investigative Site

Daventry, Northamptonshire, NN11 4DY, United Kingdom

Location

Novartis Investigative Site

Sneinton, Nottingham, NG3 7DQ, United Kingdom

Location

Novartis Investigative Site

Axbridge, Somerset, BS26 2BJ, United Kingdom

Location

Novartis Investigative Site

Frome, Somerset, BA11 2FH, United Kingdom

Location

Novartis Investigative Site

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Novartis Investigative Site

South Shields, Tyne and Wear, NE34 0PL, United Kingdom

Location

Novartis Investigative Site

Barry, Vale Of Glamorgan, CF63 1BA, United Kingdom

Location

Novartis Investigative Site

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Novartis Investigative Site

Crawley, West Sussex, RH10 7DX, United Kingdom

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Novartis Investigative Site

Trowbridge, Wiltshire, BA14 8QA, United Kingdom

Location

Novartis Investigative Site

Strensall, Yorkshire, YO32 5UA, United Kingdom

Location

Novartis Investigative Site

Bexhill-on-Sea, TN40 1JJ, United Kingdom

Location

Novartis Investigative Site

Bristol, BS10 6SP, United Kingdom

Location

Novartis Investigative Site

Bristol, BS48 1BZ, United Kingdom

Location

Novartis Investigative Site

Cardiff, CF5 4AD, United Kingdom

Location

Novartis Investigative Site

Chadderton, OL9 0LH, United Kingdom

Location

Novartis Investigative Site

Cheshire, CW1 4QJ, United Kingdom

Location

Novartis Investigative Site

Chesterfield, S40 4AA, United Kingdom

Location

Novartis Investigative Site

Chippenham, SN14 6GT, United Kingdom

Location

Novartis Investigative Site

Coventry, CV6 4DD, United Kingdom

Location

Novartis Investigative Site

Hamilton, ML3 8AA, United Kingdom

Location

Novartis Investigative Site

Lancashire, FY3 7EN, United Kingdom

Location

Novartis Investigative Site

Manchester, M8 9JT, United Kingdom

Location

Novartis Investigative Site

Motherwell, ML1 3JX, United Kingdom

Location

Novartis Investigative Site

Oldham, OL9 8NH, United Kingdom

Location

Novartis Investigative Site

Plymouth, PL5 3JB, United Kingdom

Location

Novartis Investigative Site

Shrewsbury, SY38XQ, United Kingdom

Location

Novartis Investigative Site

South Yorkshire, DN9 1EP, United Kingdom

Location

Novartis Investigative Site

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Novartis Investigative Site

Vale of Glanmorgan, CF63 4AR, United Kingdom

Location

Novartis Investigative Site

Watford, WD25 7NL, United Kingdom

Location

Novartis Investigative Site

Wiltshire, SN15 2SB, United Kingdom

Location

Novartis Investigative Site

Wishaw, ML2 0DP, United Kingdom

Location

Related Publications (2)

• Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

  PMID: 29713156 DERIVED

• Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

  PMID: 28720132 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; 3-(2-(4-azidobenzamidino)ethyl)-5-hydroxyindole

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: February 14, 2014
• Primary Completion: April 29, 2016
• Study Completion: April 29, 2016
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-03

Locations

FR (16); PT (9); BE (35); ES (39); IT (55); SL (4); LI (9); GB (44); DE (191); DK (5); IE (4); PL (8); NO (9); RO (8); LA (7); SE (11); RU (15); CZ (29); GR (3); HU (13); AU (9)