QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01315249 | Completed Phase 3 Results

• 2 other identifiers: CQVA149A23132010-023621-37
• Study Type: interventional
• Target: 523
• Locations: 8 countries
• Sites: 91

Brief Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

QVA149; indacaterol; NVA237; COPD; fluticasone/salmeterol

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12

  Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.

  Week 26

Secondary Outcomes (10)

• Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

  Week 12

• Forced Vital Capacity at All-time Points (Week 12)

  -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12

• Forced Vital Capacity at All-time Points (Week 26)

  -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26

• Focal Score of the Transitional Dyspnea Index (TDI)

  12 weeks and 26 weeks

• Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)

  12 weeks and 26 weeks

Study Arms (2)

QVA149

EXPERIMENTAL

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Drug: indacaterol and glycopyrronium (QVA149); Drug: Placebo to fluticasone/salmeterol

fluticasone/salmeterol

ACTIVE COMPARATOR

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Drug: fluticasone/salmeterol; Drug: Placebo to indacaterol and glycopyrronium (QVA149)

Interventions

indacaterol and glycopyrronium (QVA149) DRUG

QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.

QVA149

Placebo to fluticasone/salmeterol DRUG

Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.

QVA149

fluticasone/salmeterol DRUG

Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.

fluticasone/salmeterol

Placebo to indacaterol and glycopyrronium (QVA149) DRUG

Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

fluticasone/salmeterol

Eligibility Criteria

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

You may qualify if:

• Smoking history of at least 10 pack years
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2009)
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \>40% and \< 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<70%

You may not qualify if:

• Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
• Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Any patient with lung cancer or a history of lung cancer (within last 5 years)
• Patients with a history of certain cardiovascular co-morbid conditions

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (93)

Novartis Investigative Site

Malmedy, Belgium, 4960, Belgium

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Novartis Investigative Site

Luxembourg, Luxembourg, 1210, Belgium

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Novartis Investigative Site

Aalst, 9300, Belgium

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Novartis Investigative Site

Brussels, 1000, Belgium

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Novartis Investigative Site

Hasselt, 3500, Belgium

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Novartis Investigative Site

Jambes, 5100, Belgium

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Novartis Investigative Site

Jette, 1090, Belgium

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Novartis Investigative Site

Cvikov, Czech Republic, 471 54, Czechia

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Novartis Investigative Site

Jindřichův Hradec, Czech Republic, 377 01, Czechia

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Novartis Investigative Site

Mělník, Czech Republic, 276 01, Czechia

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Novartis Investigative Site

Pardubice, Czech Republic, 530 09, 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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Novartis Investigative Site

Teplice, Czech Republic, 415 01, Czechia

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Novartis Investigative Site

Kyjov, CZE, 697 70, Czechia

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Novartis Investigative Site

Tartu, Estonia, 51014, Estonia

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Novartis Investigative Site

Tallinn, 13419, Estonia

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Novartis Investigative Site

Berlin, Germany, 10117, Germany

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Novartis Investigative Site

Berlin, Germany, 14050, Germany

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Leipzig, Germany, 04207, Germany

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Saarbrücken, Germany, 66111, Germany

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Novartis Investigative Site

Aschaffenburg, 63739, Germany

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Novartis Investigative Site

Bad Wörishofen, 86825, Germany

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Novartis Investigative Site

Bamberg, 96049, Germany

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Novartis Investigative Site

Berlin, 13057, Germany

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Novartis Investigative Site

Berlin, 13086, Germany

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Novartis Investigative Site

Berlin, 13507, Germany

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Novartis Investigative Site

Berlin, 13581, Germany

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Novartis Investigative Site

Berlin, 14050, Germany

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Novartis Investigative Site

Berlin, D-12165, Germany

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Novartis Investigative Site

Bielefeld, 33617, Germany

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Novartis Investigative Site

Bochum, 44787, Germany

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Bonn, 53123, Germany

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Novartis Investigative Site

Borstel, 23845, Germany

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Novartis Investigative Site

Düren, 52349, Germany

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Novartis Investigative Site

Eschwege, 37269, Germany

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Frankfurt, 60596, Germany

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Freudenberg, 57258, Germany

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Novartis Investigative Site

Fulda, 36039, Germany

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Novartis Investigative Site

Fürstenwalde, 15517, Germany

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Novartis Investigative Site

Gelsenkirchen, 45879, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Gummersbach, 51643, Germany

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Novartis Investigative Site

Güstrow, 18273, Germany

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Novartis Investigative Site

Hagen, 59065, 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

Hanover, 30167, Germany

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Novartis Investigative Site

Hildesheim, 31134, Germany

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Novartis Investigative Site

Lübeck, 23558, Germany

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Novartis Investigative Site

München, 80539, Germany

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Novartis Investigative Site

Oschersleben, 39387, Germany

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Novartis Investigative Site

Ratingen, 40878, Germany

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Novartis Investigative Site

Rheine, 48431, Germany

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Novartis Investigative Site

Schwerte, 58239, Germany

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Novartis Investigative Site

Solingen, 42651, Germany

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Novartis Investigative Site

Ulm, 89081, Germany

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Novartis Investigative Site

Wissen, 57537, Germany

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Novartis Investigative Site

Cegléd, Hungary, 2700, Hungary

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Novartis Investigative Site

Debrecen, Hungary, 4032, Hungary

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Novartis Investigative Site

Szarvas, Hungary, 5540, Hungary

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Budapest, 1191, Hungary

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Eger, 3300, Hungary

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Gödöllő, 2100, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Novartis Investigative Site

Szeged, 6770, Hungary

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Törökbálint, 2045, Hungary

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Novartis Investigative Site

Alytus, LT-62114, Lithuania

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Novartis Investigative Site

Kaunas, 44320, Lithuania

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Novartis Investigative Site

Klaipėda, 92288, Lithuania

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Novartis Investigative Site

Klaipėda, LT-92231, Lithuania

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Novartis Investigative Site

Utena, LT-28151, Lithuania

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Novartis Investigative Site

Vilnius, 06001, Lithuania

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Novartis Investigative Site

Ålesund, 6017, Norway

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Novartis Investigative Site

Kongsvinger, 2212, Norway

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Novartis Investigative Site

Skedsmokorset, 2020, Norway

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Novartis Investigative Site

Stavanger, 4005, Norway

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Novartis Investigative Site

Trondheim, 7006, Norway

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Novartis Investigative Site

Wŏnju, Gangwon-do, 220-701, South Korea

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Novartis Investigative Site

Seoul, Seoul, 130-709, South Korea

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Novartis Investigative Site

Daegu, 705-717, South Korea

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Novartis Investigative Site

Seoul, 100-032, South Korea

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Novartis Investigative Site

Seoul, 130-702, South Korea

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Novartis Investigative Site

Seoul, 143-729, South Korea

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Novartis Investigative Site

Seoul, 152-703, South Korea

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Novartis Investigative Site

Alicante, Alicante, 03114, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08025, Spain

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Novartis Investigative Site

Sabadell, Catalonia, 08208, Spain

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Novartis Investigative Site

Sant Boi de Llobregat, Catalonia, 08830, Spain

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Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

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Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

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Novartis Investigative Site

Valladolid, Valladolid, 47011, Spain

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Related Publications (1)

• Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6.

  PMID: 24321804 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Glycopyrrolate; indacaterol-glycopyrronium combination; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

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; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis

41 61 324 1111

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 9, 2013
• Results First Posted: August 9, 2013

Record last verified: 2013-07

Locations

LI (6); HU (9); ES (7); BE (7); KR (7); DE (42); CZ (8); NO (5)