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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)

Conditions
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Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
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* Drug: QVA149
* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence 1<br>QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 | Drug: QVA149<br>* QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day<br>* Other names: indacaterol maleate/glycoporromium bromide;Drug: Tiotropium<br>* Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day<br>|
| Experimental: Treatment sequence 2<br>Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56 | Drug: QVA149<br>* QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day<br>* Other names: indacaterol maleate/glycoporromium bromide;Drug: Tiotropium<br>* Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 8 weeks |