Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00970268
First received: September 1, 2009
Last updated: August 14, 2012
Last verified: August 2012

September 1, 2009
August 14, 2012
January 2010
December 2010   (final data collection date for primary outcome measure)
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1
Change from Baseline (Visit 2 of lead-in study LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in morning predose (trough) FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00970268 on ClinicalTrials.gov Archive Site
Change From Baseline in Peak FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).
Change from Baseline (Visit 2 of LAS-MD-33) to week 52 (Week 64 from start of LAS-MD-33) in peak FEV1. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Aclidinium bromide
    Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
  • Drug: Aclidinium bromide
    Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
  • Experimental: 1
    Aclidinium bromide dose, inhaled, for 52 weeks of treatment
    Intervention: Drug: Aclidinium bromide
  • Experimental: 2
    Aclidinium bromide dose, inhaled, for 52 weeks of treatment
    Intervention: Drug: Aclidinium bromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
Not Provided
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

  • Use or anticipated use of any medication prohibited in this study
  • Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
  • The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
  • QTcB of >500 msec on both the pre-dose and post-dose ECG
  • Women who are pregnant, intend to become pregnant, or are breast-feeding
  • A life expectancy of less than 1 year
  • Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
  • Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00970268
LAS-MD-36
No
Forest Laboratories
Forest Laboratories
Almirall, S.A.
Study Director: Jordan Lateiner, MS Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Forest Laboratories
August 2012

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