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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00435760
First received: February 14, 2007
Last updated: May 2, 2011
Last verified: May 2011

February 14, 2007
May 2, 2011
February 2007
August 2007   (final data collection date for primary outcome measure)
FVE1 increase [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
equal or greater increase of 10% basal FVE1
Not Provided
Complete list of historical versions of study NCT00435760 on ClinicalTrials.gov Archive Site
Normalised FEV1 AUC 0-3h [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Not Provided

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
COPD
  • Drug: Aclidinium bromide
    200 micro grams, once daily, 1 day treatment
  • Drug: Placebo Tiotropium
    1 puff once daily, 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
  • Drug: Placebo LAS34273
    1 puff, 1 dat treatment
  • Active Comparator: Tiotropium
    1 puff, 1 day treatment
    Intervention: Drug: Tiotropium
  • Placebo Comparator: Placebo
    Tiotropium or Aclidinium Placebo, 1 day treatment
    Interventions:
    • Drug: Placebo Tiotropium
    • Drug: Placebo LAS34273
  • Experimental: Aclidinium Bromide
    200 micro grams, once daily, 1 day treatment
    Intervention: Drug: Aclidinium bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
Not Provided
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00435760
CT000860
Not Provided
Estrella Garcia, Almirall S.A.
Almirall, S.A.
Forest Laboratories
Study Director: Almirall R&D Almirall, S.A.
Almirall, S.A.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP