Chronic Obstructive Pulmonary Disease Clinical Trial
— FAVOROfficial title:
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)
Verified date | December 2015 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Bundesamt für Arzneimittel und Medizinprodukte |
Study type | Interventional |
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
Status | Completed |
Enrollment | 88 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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 | Hannover | |
Germany | Novartis Investigative Site | Ibbenbüren | Rheinland Pfalz |
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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