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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Aclidinium Bromide; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	181 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, 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
Study Start Date :	July 2007
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	September 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Aclidinium	Drug: Aclidinium Bromide; Aclidinium Bromide, 200μg. Once daily oral inhalation.
Placebo Comparator: Placebo	Drug: Placebo; Dose matched placebo, once daily oral inhalation.

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Exercise Endurance Time (ET) [ Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]
   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 :

1. Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Visit 4) at Week 6 (Visit 6) ]
   Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
2. Trough Inspiratory Capacity (IC) [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]
   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).
3. Functional Residual Capacity (FRC) [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]
   Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
4. Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]
   Ratio of trough Inspiratory Capacity verses Total Lung Capacity.

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 52 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Esther Garcia, MD	AstraZeneca

More Information

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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:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00500318 History of Changes
Other Study ID Numbers:	LAS-MD-CL26
First Posted:	July 12, 2007
Results First Posted:	December 17, 2012
Last Update Posted:	January 6, 2017
Last Verified:	November 2016

Keywords provided by AstraZeneca:

Bronchitis, Chronic; Emphysema

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Respiratory Tract Diseases; Lung Diseases, Obstructive	Disease Attributes; Pathologic Processes; Bromides; Anticonvulsants