Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

Phase 4

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

signed an Informed Consent Form
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

Pregnant or breast feeding mothers
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.

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1	QVA149	QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
Treatment sequence 1	Tiotropium	QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
Treatment sequence 2	QVA149	Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
Treatment sequence 2	Tiotropium	Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation	week 4	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.

Secondary Outcome Measures

Name	Time	Method
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.	8 weeks	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
Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.	8 weeks	Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.