Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01636076 | Completed Phase 2 Results DMC

• 2 other identifiers: CQMF149F22022012-001172-12
• Study Type: interventional
• Target: 629
• Locations: 18 countries
• Sites: 115

Brief Summary

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85

  Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

  12 weeks

Secondary Outcomes (27)

• Trough FEV1 After First Dose and After 4 Weeks of Treatment

  Day 1 and Day 85

• Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint

  Day 1 through day 85

• Forced Vital Capacity (FVC) at Each Timepoint

  Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85

• FEV1/FVC at Each Timepoint

  Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85

• FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)

  Day 1

Study Arms (2)

QMF149

EXPERIMENTAL

QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device

Drug: QMF149

Salmeterol xinafoate/fluticasone propionate

ACTIVE COMPARATOR

Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®

Drug: Salmeterol

Interventions

QMF149 DRUG

delivered via Concept1 device

QMF149

Salmeterol DRUG

delivered via Accuhaler®

Salmeterol xinafoate/fluticasone propionate

Eligibility Criteria

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

You may qualify if:

• Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
• Patients with a post-bronchodilator FEV1 \< 70% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70 at run-in (Visit 101).
• Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.

You may not qualify if:

• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (Visit 1).
• Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
• Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
• Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
• Patients requiring long term oxygen therapy prescribed for \>12 hours per day.
• Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (115)

Novartis Investigative Site

Concord, New South Wales, 2139, Australia

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Novartis Investigative Site

Kogarah, New South Wales, 2217, Australia

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Novartis Investigative Site

New Lambton Heights, New South Wales, 2305, Australia

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Novartis Investigative Site

Redcliffe, Queensland, 4020, Australia

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Novartis Investigative Site

Bedford Park, South Australia, 5042, Australia

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Novartis Investigative Site

Daw Park, South Australia, 5041, Australia

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Novartis Investigative Site

Woodville South, South Australia, 5011, Australia

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Novartis Investigative Site

Box Hill, Victoria, 3128, Australia

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Novartis Investigative Site

Fitzroy, Victoria, 3065, Australia

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Novartis Investigative Site

Franston, Victoria, 3199, Australia

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Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

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Novartis Investigative Site

Brussels, 1000, Belgium

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Novartis Investigative Site

Halen, 3545, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Rousse, Bulgaria, 7002, Bulgaria

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Novartis Investigative Site

Varna, Bulgaria, 9010, Bulgaria

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Novartis Investigative Site

Sofia, 1233, Bulgaria

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Novartis Investigative Site

Sofia, 1234, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

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Novartis Investigative Site

Veliko Tarnovo, 5000, Bulgaria

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Novartis Investigative Site

Hellerup, Denmark, DK-2900, Denmark

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Novartis Investigative Site

Hvidovre, Denmark, DK-2650, Denmark

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Novartis Investigative Site

Copenhagen NV, DK-2400, Denmark

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Novartis Investigative Site

Odense C, DK-5000, Denmark

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Novartis Investigative Site

Turku, Finland, FIN-20100, Finland

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Novartis Investigative Site

Pori, FIN-28500, Finland

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Novartis Investigative Site

Tampere, FIN-33521, Finland

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Novartis Investigative Site

Berlin, Germany, 10969, Germany

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Novartis Investigative Site

Wiesbaden, Germany, 65187, Germany

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Novartis Investigative Site

Berlin, 12203, Germany

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Novartis Investigative Site

Donaustauf, 93093, Germany

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Novartis Investigative Site

Großhansdorf, 22927, Germany

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Novartis Investigative Site

Hanover, 30167, Germany

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Novartis Investigative Site

Lübeck, 23552, Germany

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Novartis Investigative Site

Rüdersdorf, 15562, Germany

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Novartis Investigative Site

Witten, 58452, Germany

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Novartis Investigative Site

Heraklion Crete, Crete, GR-71110, Greece

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Novartis Investigative Site

Athens, Greece, 11527, Greece

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Novartis Investigative Site

Athens, Greece, GR 115 27, Greece

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Novartis Investigative Site

Larissa, Greece, GR 41110, Greece

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Novartis Investigative Site

Thessaloniki, Greece, GR 56403, Greece

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Novartis Investigative Site

Thessaloniki, Greece, GR 570 10, Greece

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Novartis Investigative Site

Athens, GR-106 76, Greece

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Novartis Investigative Site

Athens - GR, 10676, Greece

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Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

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Novartis Investigative Site

New Territories, Hong Kong, Hong Kong

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Novartis Investigative Site

Budapest, Hungary, 1036, Hungary

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Novartis Investigative Site

Nyíregyháza, Hungary, 4400, Hungary

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Novartis Investigative Site

Szarvas, Hungary, 5540, Hungary

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Novartis Investigative Site

Balasagyarmat, 2660, Hungary

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Novartis Investigative Site

Farkasgyepű, 8582, Hungary

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Novartis Investigative Site

Kapuvár, 9330, Hungary

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Novartis Investigative Site

Pécs, 7633, Hungary

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Novartis Investigative Site

Siófok, 8600, Hungary

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Novartis Investigative Site

Sopron, H-9401, Hungary

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Novartis Investigative Site

Veszprém, 8200, Hungary

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Novartis Investigative Site

Ashkelon, 78278, Israel

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Novartis Investigative Site

Haifa, 34362, Israel

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Novartis Investigative Site

Jerusalem, 91031, Israel

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Novartis Investigative Site

Jerusalem, 91120, Israel

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Novartis Investigative Site

Kfar Saba, 44281, Israel

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Novartis Investigative Site

Petah Tikva, 49100, Israel

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Novartis Investigative Site

Rehovot, 76100, Israel

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Novartis Investigative Site

Tel Aviv, 64239, Israel

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Novartis Investigative Site

Batu Caves, 68100, Malaysia

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Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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Novartis Investigative Site

Taiping, 34000, Malaysia

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Novartis Investigative Site

Gdansk, Poland, 80-211, Poland

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Novartis Investigative Site

Bialystok, 15-010, Poland

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Novartis Investigative Site

Bialystok, 15-270, Poland

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Novartis Investigative Site

Bialystok, 15-461, Poland

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Novartis Investigative Site

Iława, 14-200, Poland

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Novartis Investigative Site

Katowice, 40-752, Poland

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Novartis Investigative Site

Lodz, 90-153, Poland

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Novartis Investigative Site

Ostrów Wielkopolski, 63-400, Poland

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Novartis Investigative Site

Piła, 64-920, Poland

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Novartis Investigative Site

Poznan, 60-569, Poland

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Novartis Investigative Site

Szczecin, 71-124, Poland

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Novartis Investigative Site

Tarnów, 33-100, Poland

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Novartis Investigative Site

Wroclaw, 50-434, Poland

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Novartis Investigative Site

Constanța, Jud. Constanta, 900002, Romania

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Novartis Investigative Site

Bucharest, 020125, Romania

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Novartis Investigative Site

Bucharest, 50159, Romania

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Novartis Investigative Site

Cluj-Napoca, 400162, Romania

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Novartis Investigative Site

Cluj-Napoca, 400371, Romania

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Novartis Investigative Site

Târgu Mureş, 540136, Romania

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Novartis Investigative Site

Singapore, Singapore, 119074, Singapore

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Novartis Investigative Site

Singapore, Singapore, 169608, Singapore

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Novartis Investigative Site

Johannesburg, Gauteng, 2057, South Africa

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Novartis Investigative Site

Durban, South Africa, 4001, South Africa

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Novartis Investigative Site

Bloemfontein, 9301, South Africa

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Novartis Investigative Site

Cape Town, 7500, South Africa

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Novartis Investigative Site

Cape Town, 7505, South Africa

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Novartis Investigative Site

Cape Town, 7531, South Africa

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Novartis Investigative Site

Cape Town, 7764, South Africa

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Novartis Investigative Site

Cape Town, 7925, South Africa

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Novartis Investigative Site

eMkhomazi, 4170, South Africa

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Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08025, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

Valencia, Valencia, 46015, Spain

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Novartis Investigative Site

Gothenburg, 405 30, Sweden

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Novartis Investigative Site

Gothenburg, 412 63, Sweden

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Novartis Investigative Site

Lund, SE-221 85, Sweden

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Novartis Investigative Site

Malmo, 21152, Sweden

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Novartis Investigative Site

Vällingby, 162 68, Sweden

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Novartis Investigative Site

Taladkwan, Changwat Nonthaburi, 11000, Thailand

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Novartis Investigative Site

Bangkok, 10400, Thailand

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Novartis Investigative Site

Bangkok, 10700, Thailand

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Novartis Investigative Site

Muang, 40002, Thailand

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Novartis Investigative Site

Nakhon Naiyok, 26120, Thailand

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Novartis Investigative Site

Songkhla, 90110, Thailand

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

QMF149; Salmeterol Xinafoate

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)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2014-11

Locations

PL (13); ES (4); TH (6); DE (10); GR (8); HU (10); SG (2); AU (11); SE (5); BE (3); IL (8); FI (3); HK (2); MY (3); ZA (9); BU (8); DK (4); RO (6)