Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
NCT ID: NCT02125734
Last Updated: 2017-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
88 participants
INTERVENTIONAL
2014-04-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment sequence 1
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
QVA149
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
Tiotropium
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Treatment sequence 2
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
QVA149
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
Tiotropium
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Interventions
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QVA149
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
Tiotropium
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* stable COPD according to current guidelines (GOLD 2013)
* airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of \<0.70 and a post-bronchodilator FEV1 of ≥30% and \<80% of predicted normal values at Visit 2.
* current or ex-smokers who have a smoking history of at least 10 pack years
* Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
* Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).
Exclusion Criteria
* Patients with conditions contraindicated for treatment
* Patients with a history of clinically significant diseases
* Patients who have a clinically significant renal disease
* Patients with myocardial infarctions less than 6 months prior to study entry
* Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
* Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
* Patients with a history of malignancy of any organ system
* Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
* Patients who have had a respiratory tract infection within 6 weeks prior to Screening
* Patients with any history of asthma.
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
Ibbenbüren, Rhineland-Palatinate, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Garmisch-Partenkirchen, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Kassel, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Neu-Isenburg, , Germany
Novartis Investigative Site
Rheine, , Germany
Novartis Investigative Site
Siegen, , Germany
Novartis Investigative Site
Solingen, , Germany
Novartis Investigative Site
Sonneberg, , Germany
Novartis Investigative Site
Warendorf, , Germany
Countries
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Other Identifiers
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2013-004223-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVA149ADE04
Identifier Type: -
Identifier Source: org_study_id
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