Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01613326
Last Updated: 2014-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
657 participants
INTERVENTIONAL
2012-06-30
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
QUADRUPLE
Study Groups
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NVA237
NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
NVA237
NVA237 50 μg inhalation capsules once a day, delivered via SDDPI
Placebo to tiotropium
Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.
salbutamol/albuterol
salbutamol/albuterol given as a rescue medication via inhaler when needed
Tiotropium
Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
Tiotropium
Tiotropium 18 μg once a day delivered via HandiHaler® device
Placebo to NVA237
Placebo to NVA237 50 μg once a day delivered via SDDPI
Interventions
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NVA237
NVA237 50 μg inhalation capsules once a day, delivered via SDDPI
Tiotropium
Tiotropium 18 μg once a day delivered via HandiHaler® device
Placebo to tiotropium
Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.
Placebo to NVA237
Placebo to NVA237 50 μg once a day delivered via SDDPI
salbutamol/albuterol
salbutamol/albuterol given as a rescue medication via inhaler when needed
Eligibility Criteria
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Inclusion Criteria
* Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥ 30% and \< 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 (e.g. 10 pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs).
* Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
Exclusion Criteria
* Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1.
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered).
* Patients receiving medications in the classes listed in the protocol as prohibited.
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
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
Novartis Investigative Site
Gatineau, Quebec, Canada
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Mirabel, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
Novartis Investigative Site
Sisak, Croatia, Croatia
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Zagreb, Croatia, Croatia
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Zagreb, , Croatia
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Cvikov, Czech Republic, Czechia
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Liberec, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Rudná, Czech Republic, Czechia
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Teplice, Czech Republic, Czechia
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Žatec, Czech Republic, Czechia
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Tartu, Estonia, Estonia
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Paide, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Beuvry, France, France
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Lyon, , France
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Nantes, , France
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Reims, , France
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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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Wiesbaden, Germany, Germany
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Berlin, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Kassel, , Germany
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Potsdam, , Germany
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Rüdersdorf, , Germany
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Guatemala City, Departamento de Guatemala, Guatemala
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Guatemala City, Departamento de Guatemala, Guatemala
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Guntur, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Chennai - Tamil Nadu, India, India
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Bangalore, Karnataka, India
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Nagpur, Maharashtra, India
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Coimbatore, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Daugavpils, , 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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Utena, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Lipa City, Batangas, Philippines
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Bulacan, Philippines, Philippines
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Manila, Philippines, Philippines
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Quezon City, , Philippines
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Gdansk, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Cape Town, , South Africa
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Cape Town, , South Africa
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Gatesville, , South Africa
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Busan, Busan, South Korea
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Bucheon-si, Gyeonggi-do, South Korea
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Seoul, Seoul, 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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Chiayi City, Taiwan, Taiwan
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Niaosong Township, Taiwan, Taiwan
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Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei County, Taiwan, Taiwan
Novartis Investigative Site
Chiayi City, , Taiwan
Countries
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References
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Chapman KR, Beeh KM, Beier J, Bateman ED, D'Urzo A, Nutbrown R, Henley M, Chen H, Overend T, D'Andrea P. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014 Jan 17;14:4. doi: 10.1186/1471-2466-14-4.
Other Identifiers
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2011-000960-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNVA237A2314
Identifier Type: -
Identifier Source: org_study_id
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