The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
88
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Novartis Investigative Site
Ibbenbüren, Rhineland-Palatinate, Germany
Novartis Investigative Site
Berlin, Germany
Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Time frame: week 4
Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.
Time frame: 8 weeks
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire
Time frame: 8 weeks
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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
...and 8 more locations