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
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:October 2012
End Date:June 2014

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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.


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
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Baltimore, Maryland 21287
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Abingdon, Virginia 24210
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Corsicana, Texas 75110
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Dayton, Ohio 45402
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