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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 28, 2015
Last verified: May 2015
History of Changes

February 14, 2007
May 28, 2015
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
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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 ]
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Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
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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
Chronic Obstructive Pulmonary Disease (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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
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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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00435760
CT000860
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Estrella Garcia, Almirall S.A.
Almirall, S.A.
Forest Laboratories
Study Director: Almirall R&D Almirall, S.A.
Almirall, S.A.
May 2015

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