Clinical trial NCT00891462: Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
Official title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 561
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: The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Forest Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Forest Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site
state: California
city: Fresno
country: United States
facility: Forest Investigative Site
state: California
city: Fullerton
country: United States
facility: Forest Investigative Site
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site
state: California
city: Orange
country: United States
facility: Forest Investigative Site
state: California
city: Palo Alto
country: United States
facility: Forest Investigative Site
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site
state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Brandon
country: United States
facility: Forest Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Panama City
country: United States
facility: Forest Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: Austell
country: United States
facility: Forest Investigative Site
state: Georgia
city: Blue Ridge
country: United States
facility: Forest Investigative Site
state: Georgia
city: Duluth
country: United States
facility: Forest Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Forest Investigative Site
state: Georgia
city: River Forest
country: United States
facility: Forest Investigative Site
state: Illinois
city: Skokie
country: United States
facility: Forest Investigative Site
state: Illinois
city: South Bend
country: United States
facility: Forest Investigative Site
state: Indiana
city: Crescent Springs
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Lexington
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Lafayette
country: United States
facility: Forest Investigative Site
state: Louisiana
city: Bangor
country: United States
facility: Forest Investigative Site
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: Forest Investigative Site
state: Maryland
city: North Dartmouth
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Livonia
country: United States
facility: Forest Investigative Site
state: Michigan
city: Edina
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Florissant
country: United States
facility: Forest Investigative Site
state: Missouri
city: Saint Charles
country: United States
facility: Forest Investigative Site
state: Missouri
city: Billings
country: United States
facility: Forest Investigative Site
state: Montana
city: Butte
country: United States
facility: Forest Investigative Site
state: Montana
city: Papillion
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Berlin
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Summit
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site
state: New York
city: Buffalo
country: United States
facility: Forest Investigative Site
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site
state: New York
city: Ithaca
country: United States
facility: Forest Investigative Site
state: New York
city: New Hyde Park
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: Asheville
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site
state: Oklahoma
city: Medford
country: United States
facility: Forest Investigative Site
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Bethlehem
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Hershey
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Upland
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: East Providence
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Johnston
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Forest Investigative Site
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Tyler
country: United States
facility: Forest Investigative Site
state: Texas
city: Waco
country: United States
facility: Forest Investigative Site
state: Texas
city: Midvale
country: United States
facility: Forest Investigative Site
state: Utah
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Bellingham
country: United States
facility: Forest Investigative Site
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: Forest Investigative Site
state: Wisconsin
city: Saskatoon
country: Canada
facility: Forest Investigative Site
state: Saskatchewan
city: Edmonton
country: Canada
facility: Forest Investigative Site
city: Hamilton
country: Canada
facility: Forest Investigative Site
city: Kelowna
country: Canada
facility: Forest Investigative Site
city: Niagara Falls
country: Canada
facility: Forest Investigative Site
city: Sainte-Foy
country: Canada
facility: Forest Investigative Site
city: Toronto
country: Canada
facility: Forest Investigative Site
city: Toronto
country: Canada
facility: Forest Investigative Site
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
citation: Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.