Clinical trial to assess rate of onset of bronchodilator action in severe stable chronic obstructive pulmonary disease (COPD) patients

Study identifier:M/34273/24

ClinicalTrials.gov identifier:NCT00435760

EudraCT identifier:2005-005804-17

CTIS identifier:N/A

Study Complete

Official Title

Single dose, double-blind, double-dummy, 3 period cross-over, placebo controlled clinical trial to assess the reate of onset of action of inhaled aclidinium bromide 200µg compared to placebo and Tiotropium 18µg in patients with chronic obstructive pulmonary disease (COPD).

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

Study drug

Aclidinium bromide, Placebo Tiotropium, Tiotropium, Placebo LAS34273

Sex

All

Actual Enrollment

115

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Feb 2007

Primary Completion Date: 01 Aug 2007

Study Completion Date: 01 Aug 2007

Study design

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

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Respiratory Clinical Trials Ltd

London, United Kingdom, W1G 8HU

Arms	Assigned Interventions
Active Comparator: Tiotropium 1 puff, 1 day treatment	Drug: Tiotropium 1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
Placebo Comparator: Placebo Tiotropium or Aclidinium Placebo, 1 day treatment	Drug: Placebo Tiotropium 1 puff once daily, 1 day treatment Drug: Placebo LAS34273 1 puff, 1 dat treatment
Experimental: Aclidinium bromide 200 micrograms, once daily, 1 day treatment	Drug: Aclidinium bromide 200 micrograms, once daily, 1 day treatment

"There is no result for the study"

Documents available

Sponsor web site
Download
Co-Sponsor web site
Download
CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Esther Garcia

AstraZeneca