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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: QVA149; Drug: QAB149

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682863

CQVA149A2340

2012-001998-93

Details and patient eligibility

About

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.

Enrollment: 614 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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614 participants in 3 patient groups

QVA149 dose 1

Experimental group

Description:

QVA149 27.5/12.5 μg capsules

Treatment:

Drug: QVA149

Drug: QVA149

QVA149 dose 2

Experimental group

Description:

QVA149 27.5/25 μg capsules

Treatment:

Drug: QVA149

Drug: QVA149

QAB149

Active Comparator group

Description:

QAB149 75 μg capsules

Treatment:

Drug: Placebo

Drug: QAB149