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

Purpose

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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Aclidinium Bromide Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: COPD Exercise and Physical Fitness

Drug Information available for: Aclidinium bromide Aclidinium

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	181
Study Start Date:	July 2007
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aclidinium	Drug: Aclidinium Bromide Aclidinium Bromide, 200μg. Once daily oral inhalation.
Placebo Comparator: Placebo	Drug: Placebo Dose matched placebo, once daily oral inhalation.

Eligibility


Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500318

Show 52 Study Locations

Sponsors and Collaborators

Forest Laboratories

Almirall, S.A.

Investigators


Study Director:	Brian T Maurer, M.S.	Forest Laboratories

More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00500318 History of Changes
Other Study ID Numbers:	LAS-MD-CL26
Study First Received:	July 10, 2007
Results First Received:	August 14, 2012
Last Updated:	November 16, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Forest Laboratories:


Bronchitis, Chronic; Emphysema

Additional relevant MeSH terms:


Chronic Disease Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes	Respiratory Tract Diseases Bromides Anticonvulsants Central Nervous System Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015