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

August 10, 2006
February 13, 2013
August 2006
May 2008   (final data collection date for primary outcome measure)
  • 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
Lung function
Complete list of historical versions of study NCT00363896 on ClinicalTrials.gov Archive Site
  • 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
Exacerbations and Quality of Life
Not Provided
Not Provided
 
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Aclidinium bromide
    Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
  • Drug: Placebo
    Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
  • Experimental: Aclidinium 200 μg once-daily
    Aclidinium bromide 200 μg once-daily by inhalation
    Intervention: Drug: Aclidinium bromide
  • Placebo Comparator: Placebo
    Placebo once-daily via inhalation
    Intervention: Drug: Placebo
Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12:55. doi: 10.1186/1465-9921-12-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
843
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Spain,   Germany,   Italy,   Netherlands,   United Kingdom,   Denmark,   Russian Federation,   France,   Austria,   Bulgaria,   Czech Republic,   Hungary,   Poland,   Romania,   Andorra
 
NCT00363896
CT000740, ACCLAIM I, M/34273/30
Not Provided
Almirall, S.A.
Almirall, S.A.
Forest Laboratories
Study Director: Almirall R & D Almirall Prodesfarma
Almirall, S.A.
October 2012

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