A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01462929 Phase 3 COMPLETED Results posted

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	414
Start date	2011-11
Completion	2012-05

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

• Aclidinium bromide
• Tiotropium
• Placebo

Primary outcomes

• Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment — Week 6
  Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

Countries

Czechia, Germany, Hungary, Poland