Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01636076
Last Updated: 2014-11-17
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
PHASE2
629 participants
INTERVENTIONAL
2012-11-30
2013-09-30
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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QMF149
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
QMF149
delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Salmeterol
delivered via Accuhaler®
Interventions
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QMF149
delivered via Concept1 device
Salmeterol
delivered via Accuhaler®
Eligibility Criteria
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Inclusion Criteria
* Patients with a post-bronchodilator FEV1 \< 70% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70 at run-in (Visit 101).
* Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.
Exclusion Criteria
* Patients who develop a COPD exacerbation between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
* Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
* Patients who develop a respiratory tract infection between screening (Visit 1) and treatment (Visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection.
* Patients requiring long term oxygen therapy prescribed for \>12 hours per day.
* Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
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
Concord, New South Wales, Australia
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Kogarah, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Redcliffe, Queensland, Australia
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Bedford Park, South Australia, Australia
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Daw Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Franston, Victoria, Australia
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Nedlands, Western Australia, Australia
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Brussels, , Belgium
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Halen, , Belgium
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Liège, , Belgium
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Rousse, Bulgaria, Bulgaria
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Varna, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Hellerup, Denmark, Denmark
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Hvidovre, Denmark, Denmark
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Copenhagen NV, , Denmark
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Odense C, , Denmark
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Turku, Finland, Finland
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Pori, , Finland
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Tampere, , Finland
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Berlin, Germany, Germany
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Wiesbaden, Germany, Germany
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Berlin, , Germany
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Donaustauf, , Germany
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Frankfurt, , Germany
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Großhansdorf, , Germany
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Hanover, , Germany
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Lübeck, , Germany
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Rüdersdorf, , Germany
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Witten, , Germany
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Heraklion Crete, Crete, Greece
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Athens, Greece, Greece
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Athens, Greece, Greece
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Larissa, Greece, Greece
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Thessaloniki, Greece, Greece
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Thessaloniki, Greece, Greece
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Athens, , Greece
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Athens - GR, , Greece
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Hong Kong, Hong Kong, Hong Kong
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New Territories, Hong Kong, Hong Kong
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Budapest, Hungary, Hungary
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Nyíregyháza, Hungary, Hungary
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Szarvas, Hungary, Hungary
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Balasagyarmat, , Hungary
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Farkasgyepű, , Hungary
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Kapuvár, , Hungary
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Pécs, , Hungary
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Siófok, , Hungary
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Sopron, , Hungary
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Veszprém, , Hungary
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Ashkelon, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Batu Caves, , Malaysia
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Kuala Lumpur, , Malaysia
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Taiping, , Malaysia
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Gdansk, Poland, Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Iława, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Ostrów Wielkopolski, , Poland
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Piła, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Wroclaw, , Poland
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Constanța, Jud. Constanta, 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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Târgu Mureş, , Romania
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Johannesburg, Gauteng, South Africa
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Durban, South Africa, South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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eMkhomazi, , South Africa
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Valencia, Valencia, Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Vällingby, , Sweden
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Taladkwan, Changwat Nonthaburi, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Muang, , Thailand
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Nakhon Naiyok, , Thailand
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Songkhla, , Thailand
Countries
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Other Identifiers
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2012-001172-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQMF149F2202
Identifier Type: -
Identifier Source: org_study_id