Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01604278
Last Updated: 2014-11-14
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
449 participants
INTERVENTIONAL
2012-05-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NVA237 + indacaterol
NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Placebo to NVA237 + indacaterol
Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
Interventions
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NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or \<80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) \< 0.70 at screening.
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Symptomatic patients according to daily diary data.
Exclusion Criteria
* Women of child-bearing potential unless using adequate contraception.
* Patients with Type I or uncontrolled Type II diabetes.
* Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation
* Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
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/Bellevaux-Ligneuville, Belgium, Belgium
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Luxembourg, Luxembourg, Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Gilly, , Belgium
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Gosselies, , Belgium
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Hasselt, , Belgium
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Herentals, , Belgium
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Jambes, , Belgium
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Liège, , Belgium
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Montigny-le-Tilleul, , Belgium
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Turnhout, , Belgium
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Yvoir, , Belgium
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Rousse, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Varna, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Stara Zagora, , Bulgaria
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Athens, Greece, Greece
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Athens, GR, Greece
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Athens, GR, Greece
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Thessaloniki, GR, Greece
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Érd, Hungary, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Gödöllő, , Hungary
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Wilton, Cork, Ireland
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Moscow, , Russia
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N.Novgorod, , Russia
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Nizhny Novgorod, , Russia
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Saratov, , Russia
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Bardejov, Slovak Republic, Slovakia
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Bojnice, Slovak Republic, Slovakia
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Liptovský Hrádok, Slovak Republic, Slovakia
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Kráľovský Chlmec, Slovakia, Slovakia
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Námestovo, Slovensko, Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Málaga, Andalusia, Spain
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Barcelona, Barcelona, Spain
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Torrelavega, Cantabria, Spain
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Ponferrada, Castille and León, Spain
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Illescas, Castille-La Mancha, Spain
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Centelles, Catalonia, Spain
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Salt, Catalonia, Spain
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Sant Boi de Llobregat, Catalonia, Spain
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Viladecans, Catalonia, Spain
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Mérida, Extremadura, Spain
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Gijón, Principality of Asturias, Spain
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Ankara, Turkey, Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Yenisehir/Izmir, , Turkey (Türkiye)
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Burnhope, County Durham, United Kingdom
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Newcastle upon Tyne, Newcastle-upon-Tyne, United Kingdom
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Alderton, Suffolk, United Kingdom
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Cambridge, United KIngdom, United Kingdom
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Watford, United Kingdom, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Royal Leamington Spa, Warwickshire, United Kingdom
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Strensall, Yorkshire, United Kingdom
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Bath, , United Kingdom
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Bexhill-on-Sea, , United Kingdom
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Blackpool, , United Kingdom
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Bradford, , United Kingdom
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Chesterfield, , United Kingdom
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Huntingdon, , United Kingdom
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Manchester, , United Kingdom
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Newton Aycliffe, , United Kingdom
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Reading, , United Kingdom
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Southbourne, , United Kingdom
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Telford, , United Kingdom
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Wiltshire, , United Kingdom
Countries
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References
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Vincken W, Aumann J, Chen H, Henley M, McBryan D, Goyal P. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. Int J Chron Obstruct Pulmon Dis. 2014 Feb 24;9:215-28. doi: 10.2147/COPD.S51592. eCollection 2014.
Other Identifiers
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2011-005673-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNVA237A2316
Identifier Type: -
Identifier Source: org_study_id