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
  Purpose

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.


Condition Intervention Phase
COPD
Drug: Aclidinium bromide
Drug: Placebo Tiotropium
Drug: Tiotropium
Drug: Placebo LAS34273
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • FVE1 increase [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    equal or greater increase of 10% basal FVE1


Secondary Outcome Measures:
  • Normalised FEV1 AUC 0-3h [ Time Frame: 0-3 hours ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: February 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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 micro grams, once daily, 1 day treatment
Drug: Aclidinium bromide
200 micro grams, once daily, 1 day treatment

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435760

Locations
United Kingdom
Respiratory Clinical Trials Ltd
London, United Kingdom, W1G 8HU
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Almirall R&D Almirall, S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Estrella Garcia, Almirall S.A.
ClinicalTrials.gov Identifier: NCT00435760     History of Changes
Other Study ID Numbers: CT000860
Study First Received: February 14, 2007
Last Updated: May 2, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Almirall, S.A.:
COPD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014