A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

• Male and female adults aged ≥40 years

• Patients with stable COPD according to GOLD strategy (GOLD 2011).

• Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.

• Current or ex-smokers who have a smoking history of at least 10 pack years.

• Patients with an mMRC ≥ grade 2

Exclusion Criteria:

• History of long QT syndrome or prolonged QTc

• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.

• Patients with Type I or uncontrolled Type II diabetes

• Patients with a history of asthma or have concomitant pulmonary disease

• Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible

• Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety

• Other protocol defined inclusion/exclusion criteria may apply