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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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Faltigberg-Wald, Canton of Zurich, Switzerland
Novartis Investigative Site
Basel, Switzerland, Switzerland
Novartis Investigative Site
Locarno, Switzerland, Switzerland
Novartis Investigative Site
Barmelweid, Switzerland
Novartis Investigative Site
Bern, Switzerland
Novartis Investigative Site
Bern, Switzerland
Novartis Investigative Site
Crans-Montana, Switzerland
Novartis Investigative Site
Lausanne, Switzerland
Novartis Investigative Site
Lugano, Switzerland
Novartis Investigative Site
Sankt Gallen, Switzerland
Start Date
November 1, 2012
Primary Completion Date
June 1, 2014
Completion Date
June 1, 2014
Last Updated
February 9, 2016
79
ACTUAL participants
QAB149
DRUG
Placebo
DRUG
NVA237
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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