Efficacy and Safety of LAS 34273 in Patients With 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:

NCT00358436

First received: July 28, 2006

Last updated: February 13, 2013

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2006
Last Updated Date	February 13, 2013
Start Date ^ICMJE	July 2006
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 31, 2012)	Trough FEV1 (L) at 28 Weeks on Treatment [ Time Frame: 28 weeks ] [ Designated as safety issue: No ] Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks Trough FEV1 (L) at 12 Weeks on Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Original Primary Outcome Measures ^ICMJE (submitted: July 28, 2006)	Lung function
Change History	Complete list of historical versions of study NCT00358436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 31, 2012)	Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment [ Time Frame: 52 weeks ] [ 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 (submitted: July 28, 2006)	Exacerbations and Quality of Life
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Official Title ^ICMJE	Not Provided
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 by 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 by 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	804
Completion Date	June 2008
Primary Completion Date	June 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	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Canada, Mexico, New Zealand, South Africa

Administrative Information
NCT Number ^ICMJE	NCT00358436
Other Study ID Numbers ^ICMJE	CT000742, ACCLAIM II, M/34273/31
Has Data Monitoring Committee	Not Provided
Responsible Party	Almirall, S.A.
Study Sponsor ^ICMJE	Almirall, S.A.
Collaborators ^ICMJE	Forest Laboratories
Investigators ^ICMJE	Not Provided
Information Provided By	Almirall, S.A.
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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