QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01315249
Last Updated: 2013-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
523 participants
INTERVENTIONAL
2011-03-31
2012-03-31
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
Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
indacaterol and glycopyrronium (QVA149)
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
Placebo to fluticasone/salmeterol
Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
fluticasone/salmeterol
Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
fluticasone/salmeterol
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
Placebo to indacaterol and glycopyrronium (QVA149)
Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily
Interventions
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indacaterol and glycopyrronium (QVA149)
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
Placebo to fluticasone/salmeterol
Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
fluticasone/salmeterol
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
Placebo to indacaterol and glycopyrronium (QVA149)
Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily
Eligibility Criteria
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Inclusion Criteria
* 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%
Exclusion Criteria
* 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
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
Malmedy, Belgium, Belgium
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Luxembourg, Luxembourg, Belgium
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Aalst, , Belgium
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Brussels, , Belgium
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Hasselt, , Belgium
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Jambes, , Belgium
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Jette, , Belgium
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Cvikov, Czech Republic, Czechia
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Jindřichův Hradec, Czech Republic, Czechia
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Mělník, Czech Republic, Czechia
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Pardubice, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Teplice, Czech Republic, Czechia
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Kyjov, CZE, Czechia
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Tartu, Estonia, Estonia
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Tallinn, , Estonia
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Berlin, Germany, Germany
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Berlin, Germany, Germany
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Leipzig, Germany, Germany
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Saarbrücken, Germany, Germany
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Aschaffenburg, , Germany
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Bad Wörishofen, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Borstel, , Germany
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Düren, , Germany
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Eschwege, , Germany
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Frankfurt, , Germany
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Freudenberg, , Germany
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Fulda, , Germany
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Fürstenwalde, , Germany
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Gelsenkirchen, , Germany
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Göttingen, , Germany
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Gummersbach, , Germany
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Güstrow, , Germany
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Hagen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hildesheim, , Germany
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Lübeck, , Germany
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München, , Germany
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Oschersleben, , Germany
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Ratingen, , Germany
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Rheine, , Germany
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Schwerte, , Germany
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Solingen, , Germany
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Ulm, , Germany
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Wissen, , Germany
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Cegléd, Hungary, Hungary
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Debrecen, Hungary, Hungary
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Szarvas, Hungary, Hungary
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Budapest, , Hungary
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Eger, , Hungary
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Gödöllő, , Hungary
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Mosonmagyaróvár, , Hungary
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Szeged, , Hungary
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Törökbálint, , Hungary
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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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Utena, , Lithuania
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Vilnius, , Lithuania
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Ålesund, , Norway
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Kongsvinger, , Norway
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Skedsmokorset, , Norway
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Stavanger, , Norway
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Trondheim, , Norway
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Wŏnju, Gangwon-do, South Korea
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Seoul, Seoul, South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Alicante, Alicante, Spain
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Barcelona, Catalonia, Spain
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Sabadell, Catalonia, Spain
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Sant Boi de Llobregat, Catalonia, Spain
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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Valladolid, Valladolid, Spain
Countries
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References
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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.
Other Identifiers
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2010-023621-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVA149A2313
Identifier Type: -
Identifier Source: org_study_id