Clinical trial NCT00970268: Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Official title: A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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: 2009-09-02
Enrollment: 291
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 extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.


Eligibility criteria: Inclusion Criteria:

* Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

* Use or anticipated use of any medication prohibited in this study
* Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
* The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
* QTcB of \>500 msec on both the pre-dose and post-dose ECG
* Women who are pregnant, intend to become pregnant, or are breast-feeding
* A life expectancy of less than 1 year
* Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
* Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Primary outcomes:
measure: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
timeFrame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Peak FEV1
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 1162
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site 1127
state: Alabama
city: Glendale
country: United States
facility: Forest Investigative Site 0909
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 2060
state: Arizona
city: Fullerton
country: United States
facility: Forest Investigative Site 2065
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site 1088
state: California
city: Orange
country: United States
facility: Forest Investigative Site 1122
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site 2029
state: California
city: Riverside
country: United States
facility: Forets Investigative Site 2064
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 0517
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 2009
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site 1137
state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative Site 2100
state: Connecticut
city: Brandon
country: United States
facility: Forest Investigative Site 1154
state: Florida
city: Clearwater
country: United States
facility: Forest Investigative Site 1152
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site 0670
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 0990
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site 1167
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site 1060
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 0974
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 2082
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 2053
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 2047
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 1185
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 1183
state: Georgia
city: Austell
country: United States
facility: Forest Investigative Site 0987
state: Georgia
city: Blue Ridge
country: United States
facility: Forest Investigative Site 1101
state: Georgia
city: Decatur
country: United States
facility: Forest Investigative Site 1180
state: Georgia
city: Duluth
country: United States
facility: Forest Investigative Site 1161
state: Georgia
city: River Forest
country: United States
facility: Forest Investigative Site 2051
state: Illinois
city: Skokie
country: United States
facility: Forest Investigative Site 0989
state: Illinois
city: South Bend
country: United States
facility: Forest Investigative Site 1149
state: Indiana
city: Crescent Springs
country: United States
facility: Forest Investigative Site 2085
state: Kentucky
city: Lexington
country: United States
facility: Forest Investigative Site 0539
state: Kentucky
city: Lafayette
country: United States
facility: Forest Investigative Site 2024
state: Louisiana
city: Biddeford
country: United States
facility: Forest Investigative Site 2040
state: Maine
city: Edina
country: United States
facility: Forest Investigative Site 1128
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site 2041
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site 1124
state: Minnesota
city: Florissant
country: United States
facility: Forest Investigative Site 1100
state: Missouri
city: St. Charles
country: United States
facility: Forest Investigative Site 2079
state: Missouri
city: Butte
country: United States
facility: Forest Investigative Site 2067
state: Montana
city: Papillion
country: United States
facility: Forest Investigative Site 1169
state: Nebraska
city: Berlin
country: United States
facility: Forest Investigative Site 1150
state: New Jersey
city: Summit
country: United States
facility: Forest Investigative Site 2084
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 1147
state: New York
city: Elmira
country: United States
facility: Forest Investigative Site 1119
state: New York
city: New Hyde Park
country: United States
facility: Forest Investigative Site 1151
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1141
state: New York
city: New York
country: United States
facility: Forest Investigative Site 1163
state: New York
city: Asheville
country: United States
facility: Forest Investigative Site 1130
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 1134
state: Ohio
city: Centerville
country: United States
facility: Forest Investigative Site 1181
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 1136
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 2007
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 2028
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 0959
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 2006
state: Ohio
city: Medford
country: United States
facility: Forest Investigative Site 2043
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 1106
state: Oregon
city: Bethlehem
country: United States
facility: Forest Investigative Site 1126
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 2016
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 1146
state: Pennsylvania
city: Upland
country: United States
facility: Forest Investigative Site 1158
state: Pennsylvania
city: East Providence
country: United States
facility: Forest Investigative Site 1089
state: Rhode Island
city: Johnston
country: United States
facility: Forest Investigative Site 1144
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site 2072
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 1078
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site 2080
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 1121
state: South Carolina
city: Dallas
country: United States
facility: Forest Investigative Site 1155
state: Texas
city: Fort Worth
country: United States
facility: Forest Investigative Site 2012
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 1165
state: Texas
city: Waco
country: United States
facility: Forest Investigative Site 1129
state: Texas
city: Richmond
country: United States
facility: Forest Investigative Site 2099
state: Virginia
city: Spokane
country: United States
facility: Forest Investigative Site 1142
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site 0988
state: Washington
city: Kelowna
country: Canada
facility: Forest Investigative Site 2201
state: British Columbia
city: Vancouver
country: Canada
facility: Forest Investigative Site 1177
state: British Columbia
city: Niagara Falls
country: Canada
facility: Forest Investigative Site 2200
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 1168
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 1171
state: Ontario
city: Toronto
country: Canada
facility: Forest Investigative Site 2203
state: Ontario
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References:
citation: D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16.