Chronic Obstructive Pulmonary Disease: COPD Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.
The study purpose is to evaluate the effect of QAB149
- NVA237 vs. QAB149 on static lung hyperinflation.
This is a multicenter, randomized, double-blinded, single-dose, cross-over,
placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of
a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory
Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits
with two single doses of treatment. Patients will be randomized in a cross-over manner.
Treatment visits will be separated by a study medication wash-out period.Treatments will be
administered in a blinded fashion.
The patients will be male and female patients, ≥40 years of age, with a documented diagnosis
of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung
Disease (GOLD) criteria and >10-pack years history of smoking, FEV1 <80% and ≥30% of the
predicted normal value.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment