Clinical trial NCT00358436: Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lung function
Exacerbations
Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 804
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: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Eligibility criteria: Inclusion Criteria:

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Primary outcomes:
measure: Trough FEV1 (L) at 28 Weeks on Treatment
timeFrame: 28 weeks
measure: Trough FEV1 (L) at 12 Weeks on Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
timeFrame: 52 weeks
measure: Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Jasper
country: United States
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state: Alabama
city: Ozark
country: United States
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state: Alabama
city: Phoenix
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Little Rock
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state: Arkansas
city: Carmichael
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state: California
city: Encinitas
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state: California
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state: California
city: Rancho Mirage
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state: California
city: Riverside
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state: California
city: San Diego
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state: California
city: San Diego
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state: California
city: Torrance
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state: California
city: Walnut Creek
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state: California
city: Denver
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state: Colorado
city: Fort Collins
country: United States
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state: Colorado
city: Wheat Ridge
country: United States
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state: Colorado
city: Waterbury
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state: Connecticut
city: Bay Pines
country: United States
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state: Florida
city: Clearwater
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state: Florida
city: Deland
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state: Florida
city: Melbourne
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state: Florida
city: Tamarac
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state: Florida
city: Tampa
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city: Tampa
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city: Atlanta
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state: Georgia
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state: Georgia
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state: Georgia
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state: Louisiana
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state: Nebraska
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state: North Carolina
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country: Australia
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country: Australia
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country: Australia
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country: Canada
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city: Kelowna
country: Canada
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city: Montreal
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city: Niagara Falls
country: Canada
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city: Ottawa
country: Canada
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city: Ottawa
country: Canada
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city: Toronto, Ontario
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city: Monterrey
country: Mexico
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city: Zapopan
country: Mexico
facility: Almirall Investigational Sites#826
city: Auckland
country: New Zealand
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city: Grafton
country: New Zealand
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city: Tauranga
country: New Zealand
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city: Amanzimtoti
country: South Africa
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city: Bloemfontain
country: South Africa
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city: Bloemfontein
country: South Africa
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city: Cape Town
country: South Africa
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city: Cape Town
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city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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city: Durban
country: South Africa
facility: Almirall Investigational Sites#834
city: Johannesburg
country: South Africa
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Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.