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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2006

Last Updated Date

February 13, 2013

Start Date ^ICMJE

August 2006

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Lung function

Change History

Complete list of historical versions of study NCT00363896 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Exacerbations and Quality of Life

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

843

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Andorra, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russian Federation, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00363896

Other Study ID Numbers ^ICMJE

CT000740, ACCLAIM I, M/34273/30

Has Data Monitoring Committee

Not Provided

Responsible Party

Almirall, S.A.

Study Sponsor ^ICMJE

Almirall, S.A.

Collaborators ^ICMJE

Forest Laboratories

Investigators ^ICMJE

Study Director:

Almirall R & D

Almirall Prodesfarma

Information Provided By

Almirall, S.A.

Verification Date

October 2012

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

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