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Trial record 15 of 1231 for:    Lung Diseases, Obstructive: Clinical trials

A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00363896
First received: August 10, 2006
Last updated: February 13, 2013
Last verified: October 2012
  Purpose

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium bromide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Trough FEV1 (L) at 28 Weeks on Treatment [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

  • Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks


Secondary Outcome Measures:
  • Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    Time to first moderate or severe exacerbation:

    Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.


  • Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score


Enrollment: 843
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
Drug: Aclidinium bromide
Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Placebo Comparator: Placebo
Placebo once-daily via inhalation
Drug: Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

  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 with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

  • History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
  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: NCT00363896

  Show 132 Study Locations
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Almirall R & D Almirall Prodesfarma
  More Information

Additional Information:
No publications provided by Almirall, S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00363896     History of Changes
Other Study ID Numbers: CT000740, ACCLAIM I, M/34273/30
Study First Received: August 10, 2006
Results First Received: August 14, 2012
Last Updated: February 13, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Almirall, S.A.:
COPD
Lung function
Exacerbations
Quality of Life

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014