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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)

NCT ID: NCT00970268

Last Updated: 2017-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

2

Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Interventions

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Aclidinium bromide

Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Intervention Type DRUG

Aclidinium bromide

Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Forest Investigative Site 1162

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 1127

Mobile, Alabama, United States

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Forest Investigative Site 0909

Glendale, Arizona, United States

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Forest Investigative Site 2060

Phoenix, Arizona, United States

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Forest Investigative Site 2065

Fullerton, California, United States

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Forest Investigative Site 1088

Lakewood, California, United States

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Forest Investigative Site 1122

Orange, California, United States

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Forest Investigative Site 2029

Rancho Mirage, California, United States

Site Status

Forets Investigative Site 2064

Riverside, California, United States

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Forest Investigative Site 0517

Sacramento, California, United States

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Forest Investigative Site 2009

San Diego, California, United States

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Forest Investigative Site 1137

Colorado Springs, Colorado, United States

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Forest Investigative Site 2100

Waterbury, Connecticut, United States

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Forest Investigative Site 1154

Brandon, Florida, United States

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Forest Investigative Site 1152

Clearwater, Florida, United States

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Forest Investigative Site 0670

DeLand, Florida, United States

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Forest Investigative Site 0990

Fort Lauderdale, Florida, United States

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Forest Investigative Site 1167

Melbourne, Florida, United States

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Forest Investigative Site 1060

Ormond Beach, Florida, United States

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Forest Investigative Site 0974

Pensacola, Florida, United States

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Forest Investigative Site 2082

Tamarac, Florida, United States

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Forest Investigative Site 2053

Tampa, Florida, United States

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Forest Investigative Site 2047

Tampa, Florida, United States

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Forest Investigative Site 1185

Winter Park, Florida, United States

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Forest Investigative Site 1183

Atlanta, Georgia, United States

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Forest Investigative Site 0987

Austell, Georgia, United States

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Forest Investigative Site 1101

Blue Ridge, Georgia, United States

Site Status

Forest Investigative Site 1180

Decatur, Georgia, United States

Site Status

Forest Investigative Site 1161

Duluth, Georgia, United States

Site Status

Forest Investigative Site 2051

River Forest, Illinois, United States

Site Status

Forest Investigative Site 0989

Skokie, Illinois, United States

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Forest Investigative Site 1149

South Bend, Indiana, United States

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Forest Investigative Site 2085

Crescent Springs, Kentucky, United States

Site Status

Forest Investigative Site 0539

Lexington, Kentucky, United States

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Forest Investigative Site 2024

Lafayette, Louisiana, United States

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Forest Investigative Site 2040

Biddeford, Maine, United States

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Forest Investigative Site 1128

Edina, Minnesota, United States

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Forest Investigative Site 2041

Minneapolis, Minnesota, United States

Site Status

Forest Investigative Site 1124

Minneapolis, Minnesota, United States

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Forest Investigative Site 1100

Florissant, Missouri, United States

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Forest Investigative Site 2079

Saint Charles, Missouri, United States

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Forest Investigative Site 2067

Butte, Montana, United States

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Forest Investigative Site 1169

Papillion, Nebraska, United States

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Forest Investigative Site 1150

Berlin, New Jersey, United States

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Forest Investigative Site 2084

Summit, New Jersey, United States

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Forest Investigative Site 1147

Brooklyn, New York, United States

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Forest Investigative Site 1119

Elmira, New York, United States

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Forest Investigative Site 1151

New Hyde Park, New York, United States

Site Status

Forest Investigative Site 1141

New York, New York, United States

Site Status

Forest Investigative Site 1163

New York, New York, United States

Site Status

Forest Investigative Site 1130

Asheville, North Carolina, United States

Site Status

Forest Investigative Site 1134

Canton, Ohio, United States

Site Status

Forest Investigative Site 1181

Centerville, Ohio, United States

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Forest Investigative Site 1136

Cincinnati, Ohio, United States

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Forest Investigative Site 2007

Cincinnati, Ohio, United States

Site Status

Forest Investigative Site 2028

Cincinnati, Ohio, United States

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Forest Investigative Site 0959

Columbus, Ohio, United States

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Forest Investigative Site 2006

Columbus, Ohio, United States

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Forest Investigative Site 2043

Medford, Oregon, United States

Site Status

Forest Investigative Site 1106

Portland, Oregon, United States

Site Status

Forest Investigative Site 1126

Bethlehem, Pennsylvania, United States

Site Status

Forest Investigative Site 2016

Erie, Pennsylvania, United States

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Forest Investigative Site 1146

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 1158

Upland, Pennsylvania, United States

Site Status

Forest Investigative Site 1089

East Providence, Rhode Island, United States

Site Status

Forest Investigative Site 1144

Johnston, Rhode Island, United States

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Forest Investigative Site 2072

Charleston, South Carolina, United States

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Forest Investigative Site 1078

Greenville, South Carolina, United States

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Forest Investigative Site 2080

Greer, South Carolina, United States

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Forest Investigative Site 1121

Spartanburg, South Carolina, United States

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Forest Investigative Site 1155

Dallas, Texas, United States

Site Status

Forest Investigative Site 2012

Fort Worth, Texas, United States

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Forest Investigative Site 1165

San Antonio, Texas, United States

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Forest Investigative Site 1129

Waco, Texas, United States

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Forest Investigative Site 2099

Richmond, Virginia, United States

Site Status

Forest Investigative Site 1142

Spokane, Washington, United States

Site Status

Forest Investigative Site 0988

Tacoma, Washington, United States

Site Status

Forest Investigative Site 2201

Kelowna, British Columbia, Canada

Site Status

Forest Investigative Site 1177

Vancouver, British Columbia, Canada

Site Status

Forest Investigative Site 2200

Niagara Falls, Ontario, Canada

Site Status

Forest Investigative Site 1168

Toronto, Ontario, Canada

Site Status

Forest Investigative Site 1171

Toronto, Ontario, Canada

Site Status

Forest Investigative Site 2203

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 23679347 (View on PubMed)

Other Identifiers

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LAS-MD-36

Identifier Type: -

Identifier Source: org_study_id

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