A double-blind, placebo-controlled, crossover study to assess the effect of aclidinium bromide 400 μg bid on COPD symptoms and sleep quality after 3 weeks of treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD)

Study identifier:M/34273/47

ClinicalTrials.gov identifier:NCT02153489

EudraCT identifier:2013-003373-10

CTIS identifier:N/A

Study Complete

Official Title

A pilot, double-blind, placebo-controlled, 2-period crossover study to assess the effect of aclidinium bromide 400 μg bid on COPD symptoms and sleep quality after 3 weeks of treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 4

Healthy volunteers

No

Study drug

Aclidinium bromide, Placebo

Sex

All

Actual Enrollment

30

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Jun 2015
Study Completion Date: 01 Jun 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria