A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00500318
First received: July 10, 2007
Last updated: November 16, 2012
Last verified: November 2012

July 10, 2007
November 16, 2012
July 2007
December 2008   (final data collection date for primary outcome measure)
Change From Baseline in Exercise Endurance Time (ET) [ Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
Endurance time (ET) at 75% Wmax
Complete list of historical versions of study NCT00500318 on ClinicalTrials.gov Archive Site
  • Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Visit 4) at Week 6 (Visit 6) ] [ Designated as safety issue: No ]
    Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
  • Trough Inspiratory Capacity (IC) [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]
    Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
  • Functional Residual Capacity (FRC) [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]
    Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
  • Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]
    Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Trough Forced Expiratory Volume in 1 second (FEV1), Inspiratory Capacity (IC), Functional Residual Capacity (FRC), IC/Total Lung Capacity (TLC) ratio, Safety
Not Provided
Not Provided
 
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Aclidinium Bromide
    Aclidinium Bromide, 200μg. Once daily oral inhalation.
  • Drug: Placebo
    Dose matched placebo, once daily oral inhalation.
  • Experimental: Aclidinium
    Intervention: Drug: Aclidinium Bromide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
Not Provided
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
  • Current or former cigarette smoker
  • Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
  • Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

  • History of presence of asthma, allergic rhinitis, or atopy
  • Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
  • Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
  • Clinically significant respiratory conditions other than COPD
  • Chronic use of oxygen therapy >= 15 hours a day
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00500318
LAS-MD-CL26
Not Provided
Forest Laboratories
Forest Laboratories
Almirall, S.A.
Study Director: Brian T Maurer, M.S. Forest Laboratories
Forest Laboratories
November 2012

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