A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
NCT ID: NCT02371629
Last Updated: 2019-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
776 participants
INTERVENTIONAL
2015-06-24
2016-11-16
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
DOUBLE
Study Groups
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NVA237 Twice daily
Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.
NVA237
NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1
Salbutamol
All patients received salbutamol (100 μg) as only rescue medication
NVA237 Once daily
Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.
NVA237
NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1
Placebo
Placebo to NVA237
Salbutamol
All patients received salbutamol (100 μg) as only rescue medication
Interventions
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NVA237
NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1
Placebo
Placebo to NVA237
Salbutamol
All patients received salbutamol (100 μg) as only rescue medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female adults aged ≥40 years
* Patients with stable COPD according to the current GOLD strategy (GOLD 2014)
* Current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening
* mMRC grade of at least 2 at Visit 101
* Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30 % and \< 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70 at Visit 101.
Exclusion Criteria
* Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (\>450 ms for males and \>460 for females) and confirmed by a central assessor
* Patients requiring long term oxygen therapy prescribed for \>12 h per day; Patients with any history of asthma.
41 Years
84 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Genk, Limburg, Belgium
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Jambes, Namur, Belgium
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Sevlievo, Gabrovo, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Gabrovo, , Bulgaria
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Kozloduy, , Bulgaria
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Lom, , Bulgaria
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Lovech, , Bulgaria
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Montana, , Bulgaria
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Razgrad, , Bulgaria
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Roman, , Bulgaria
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Rousse, , Bulgaria
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Silistra, , Bulgaria
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Sliven, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Troyan Municipality, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vidin, , Bulgaria
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Turku, , Finland
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Heidelberg, Baden-Wurttemberg, Germany
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Hanover, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Koblenz, Rhineland-Palatinate, Germany
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Großhansdorf, Schleswig-Holstein, Germany
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Berlin, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Greifswald, , Germany
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Lübeck, , Germany
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Schwerin, , Germany
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Wiesbaden, , Germany
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Balassagyarmat, , Hungary
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Debrecen, , Hungary
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Farkasgyepű, , Hungary
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Pécs, , Hungary
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Sopron, , Hungary
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Szarvas, , Hungary
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Szeged, , Hungary
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Rehovot, , Israel
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Tarnów, Lesser Poland Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lodz, Lódzkie, Poland
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Chorzów, Silesian Voivodeship, Poland
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Bialystok, , Poland
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Gdansk, , Poland
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Kielce, , Poland
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Lodz, , Poland
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Sopot, , Poland
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Wilkowice, , Poland
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Craiova, Dolj, Romania
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Constanța, Jud. Constanta, Romania
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Tg Mures, Mureș County, Romania
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Timișoara, Timiș County, Romania
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Baia Mare, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Kazan', Tatarstan Republic, Russia
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Chelyabinsk, , Russia
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Izhevsk, , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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N.Novgorod, , Russia
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Nizhny Novgorod, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Sestroretsk, , Russia
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Smolensk, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Malmo, Skåne County, Sweden
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Lidingo, Södermanland County, Sweden
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Gothenburg, Västra Götaland County, Sweden
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Lund, , Sweden
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Linköping, Östergötland County, Sweden
Countries
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Other Identifiers
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CNVA237A2320
Identifier Type: -
Identifier Source: org_study_id
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