Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
339 participants
INTERVENTIONAL
2010-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QVA149
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
QVA149
capsules for inhalation, delivered by an SDDPI
Placebo
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Placebo
capsules for inhalation, delivered by an SDDPI
Interventions
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QVA149
capsules for inhalation, delivered by an SDDPI
Placebo
capsules for inhalation, delivered by an SDDPI
Eligibility Criteria
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Inclusion Criteria
* Smoking history of at least 10 pack years
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
Exclusion Criteria
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Mirabel, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Beuvry, France, France
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Ferolles-Attily, France, France
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Montpellier, , France
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Nantes, , France
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Pessac, , France
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Aszód, , Hungary
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Baja, , Hungary
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Érd, , Hungary
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Gödöllő, , Hungary
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Makó, , Hungary
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Chennai - Tamil Nadu, India, India
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Banglaore, Karnataka, India
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Mysore, Karnataka, India
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Indore, Madhya Pradesh, India
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Mumbai, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Dehli, New Delhi, India
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Coimbatore, Tamil Nadu, India
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Mangalore, , India
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Riga, LV, Latvia
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Daugavpils, , Latvia
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Jēkabpils, , Latvia
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Riga, , Latvia
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Bucharest, District 1, Romania
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Bucharest, District 1, Romania
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Bucharest, District 3, Romania
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Brasov, Jud. Brasov, Romania
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Iași, Jud. Iasi, Romania
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Pretoria, , South Africa
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Pretoria, , South Africa
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Busan, Busan, South Korea
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Koyang-si, Gyeonggi-do, South Korea
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Seoul, Seoul, South Korea
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Seoul, , South Korea
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Cambridge, United KIngdom, United Kingdom
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Watford, United Kingdom, United Kingdom
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Bath, , United Kingdom
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Bath, , United Kingdom
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Chesterfield, , United Kingdom
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Glasgow, , United Kingdom
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Irvine, , United Kingdom
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Lancashire, , United Kingdom
Novartis Investigative Site
Wellingborough, , United Kingdom
Countries
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References
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Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.
Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.
Other Identifiers
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2009-013235-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVA149A2307
Identifier Type: -
Identifier Source: org_study_id