Clinical trial NCT00500318: A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Bronchitis, Chronic; Emphysema
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 181
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Exercise Endurance Time (ET)
timeFrame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Change from baseline (Visit 4) at Week 6 (Visit 6)
measure: Trough Inspiratory Capacity (IC)
timeFrame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
measure: Functional Residual Capacity (FRC)
timeFrame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
measure: Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
timeFrame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Forest Investigative Site 2088
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 0909
state: Arizona
city: Long Beach
country: United States
facility: Forest Investigative Site 0957
state: California
city: Los Angeles,
country: United States
facility: Forest Investigative Site 0973
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 0887
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 0988
state: California
city: Torrance
country: United States
facility: Forest Investigative Site 0885
state: California
city: Clearwater
country: United States
facility: Forest Investigative Site 2663
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 1030
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 0974
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 0980
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 0991
state: Georgia
city: Austell
country: United States
facility: Forest Investigative Site 0987
state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site 2008
state: Georgia
city: Iowa City
country: United States
facility: Forest Investigative Site 0984
state: Iowa
city: Topeka
country: United States
facility: Forest Investigative Site 1080
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site 0898
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site 0886
state: Massachusetts
city: N. Dartmouth
country: United States
facility: Forest Investigative Site 1029
state: Massachusetts
city: Livonia
country: United States
facility: Forest Investigative Site 0889
state: Michigan
city: St. Charles
country: United States
facility: Forest Investigative Site 2079
state: Missouri
city: Omaha
country: United States
facility: Forest Investigative Site 2071
state: Nebraska
city: Brooklyn
country: United States
facility: Forest Investigative Site 0972
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site 0971
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1114
state: New York
city: New York
country: United States
facility: Forest Investigative Site 2665
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 2081
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 0688
state: North Carolina
city: Toledo
country: United States
facility: Forest Investigative Site 0981
state: Ohio
city: Hershey
country: United States
facility: Forest Investigative Site 1057
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 0888
state: Pennsylvania
city: Scranton
country: United States
facility: Forest Investigative Site 0983
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 2072
state: South Carolina
city: Columbia
country: United States
facility: Forest Investigative Site 1107
state: South Carolina
city: Columbia
country: United States
facility: Forest Investigative Site 0979
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 1078
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 0900
state: South Carolina
city: Nashville
country: United States
facility: Forest Investigative Site 0962
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 1082
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 2058
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 0890
state: Texas
city: Midvale
country: United States
facility: Forest Investigative Site 0977
state: Utah
city: Edmonton
country: Canada
facility: Forest Investigative Site 0968
state: Alberta
city: Kelowna
country: Canada
facility: Forest Investigative Site 0960
state: British Columbia
city: Vancouver
country: Canada
facility: Forest Investigative Site 0905
state: British Columbia
city: Winnipeg
country: Canada
facility: Forest Investigative Site 0976
state: Manitoba
city: Hamilton
country: Canada
facility: Forest Investigative Site 0891
state: Ontario
city: Ottawa
country: Canada
facility: Forest Investigative Site 2204
state: Ontario
city: Windsor
country: Canada
facility: Forest Investigative Site 0969
state: Ontario
city: Montreal
country: Canada
facility: Forest Investigative Site 2205
state: Quebec
city: Ste-Foy
country: Canada
facility: Forest Investigative Site 0893
state: Quebec
city: Saskatoon
country: Canada
facility: Forest Investigative Site 0943
state: Saskatchewan
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: 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.