Status:

COMPLETED

Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Lead Sponsor:

AstraZeneca

Conditions:

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility:

All Genders

40+ years

Phase:

PHASE3

Brief Summary

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

Detailed Description

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Eligibility Criteria

Inclusion

  • Males and females aged ≥ 40 years
  • Current or ex-smokers of ≥ 10 pack-year
  • Clinical diagnosis of severe stable COPD

Exclusion

  • History or current diagnosis of asthma, allergic rhinitis, or atopy
  • Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
  • Hospitalised for an acute COPD exacerbation in the last 3 months
  • Evidence of contraindicated use of anticholinergic drugs

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2007

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT00435760

Start Date

February 1 2007

End Date

August 1 2007

Last Update

November 17 2016

Active Locations (1)

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Respiratory Clinical Trials Ltd

London, United Kingdom, W1G 8HU

Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients | DecenTrialz