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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bromides; Glycopyrrolate; Tiotropium Bromide

Criteria

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.