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)

NCT00970268 | Completed Phase 3 Results

• 1 other identifier: LAS-MD-36
• Study Type: interventional
• Target: 291
• Locations: 2 countries
• Sites: 83

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.

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)

  Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1

  Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks

Secondary Outcomes (1)

• Change From Baseline in Peak FEV1

  52 weeks

Study Arms (2)

1

EXPERIMENTAL

Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Drug: Aclidinium bromide

2

EXPERIMENTAL

Aclidinium bromide dose, inhaled, for 52 weeks of treatment

Drug: Aclidinium bromide

Interventions

Aclidinium bromide DRUG

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

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of a lead-in study (NCT00891462)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (83)

Forest Investigative Site 1162

Birmingham, Alabama, 35209, United States

Location

Forest Investigative Site 1127

Mobile, Alabama, 36608, United States

Location

Forest Investigative Site 0909

Glendale, Arizona, 85306, United States

Location

Forest Investigative Site 2060

Phoenix, Arizona, 85023, United States

Location

Forest Investigative Site 2065

Fullerton, California, 92835, United States

Location

Forest Investigative Site 1088

Lakewood, California, 90712, United States

Location

Forest Investigative Site 1122

Orange, California, 92868, United States

Location

Forest Investigative Site 2029

Rancho Mirage, California, 92270, United States

Location

Forets Investigative Site 2064

Riverside, California, 92506, United States

Location

Forest Investigative Site 0517

Sacramento, California, 95821, United States

Location

Forest Investigative Site 2009

San Diego, California, 92120, United States

Location

Forest Investigative Site 1137

Colorado Springs, Colorado, 80907, United States

Location

Forest Investigative Site 2100

Waterbury, Connecticut, 06708, United States

Location

Forest Investigative Site 1154

Brandon, Florida, 33511, United States

Location

Forest Investigative Site 1152

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 0670

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 0990

Fort Lauderdale, Florida, 33316, United States

Location

Forest Investigative Site 1167

Melbourne, Florida, 32935, United States

Location

Forest Investigative Site 1060

Ormond Beach, Florida, 32174, United States

Location

Forest Investigative Site 0974

Pensacola, Florida, 32504, United States

Location

Forest Investigative Site 2082

Tamarac, Florida, 33321, United States

Location

Forest Investigative Site 2053

Tampa, Florida, 33606, United States

Location

Forest Investigative Site 2047

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 1185

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 1183

Atlanta, Georgia, 30329, United States

Location

Forest Investigative Site 0987

Austell, Georgia, 30106, United States

Location

Forest Investigative Site 1101

Blue Ridge, Georgia, 30513, United States

Location

Forest Investigative Site 1180

Decatur, Georgia, 30033, United States

Location

Forest Investigative Site 1161

Duluth, Georgia, 30096, United States

Location

Forest Investigative Site 2051

River Forest, Illinois, 60305, United States

Location

Forest Investigative Site 0989

Skokie, Illinois, 60076, United States

Location

Forest Investigative Site 1149

South Bend, Indiana, 46617, United States

Location

Forest Investigative Site 2085

Crescent Springs, Kentucky, 41017, United States

Location

Forest Investigative Site 0539

Lexington, Kentucky, 40504, United States

Location

Forest Investigative Site 2024

Lafayette, Louisiana, 70503, United States

Location

Forest Investigative Site 2040

Biddeford, Maine, 04005, United States

Location

Forest Investigative Site 1128

Edina, Minnesota, 55435, United States

Location

Forest Investigative Site 2041

Minneapolis, Minnesota, 55402, United States

Location

Forest Investigative Site 1124

Minneapolis, Minnesota, 55407, United States

Location

Forest Investigative Site 1100

Florissant, Missouri, 63033, United States

Location

Forest Investigative Site 2079

Saint Charles, Missouri, 63301, United States

Location

Forest Investigative Site 2067

Butte, Montana, 59701, United States

Location

Forest Investigative Site 1169

Papillion, Nebraska, 68406, United States

Location

Forest Investigative Site 1150

Berlin, New Jersey, 08009, United States

Location

Forest Investigative Site 2084

Summit, New Jersey, 07901, United States

Location

Forest Investigative Site 1147

Brooklyn, New York, 11234, United States

Location

Forest Investigative Site 1119

Elmira, New York, 14901, United States

Location

Forest Investigative Site 1151

New Hyde Park, New York, 11040, United States

Location

Forest Investigative Site 1141

New York, New York, 10016, United States

Location

Forest Investigative Site 1163

New York, New York, 10016, United States

Location

Forest Investigative Site 1130

Asheville, North Carolina, 28801, United States

Location

Forest Investigative Site 1134

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 1181

Centerville, Ohio, 45459, United States

Location

Forest Investigative Site 1136

Cincinnati, Ohio, 45227, United States

Location

Forest Investigative Site 2007

Cincinnati, Ohio, 45231, United States

Location

Forest Investigative Site 2028

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 0959

Columbus, Ohio, 43215, United States

Location

Forest Investigative Site 2006

Columbus, Ohio, 43215, United States

Location

Forest Investigative Site 2043

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 1106

Portland, Oregon, 97213, United States

Location

Forest Investigative Site 1126

Bethlehem, Pennsylvania, 18020, United States

Location

Forest Investigative Site 2016

Erie, Pennsylvania, 16506, United States

Location

Forest Investigative Site 1146

Pittsburgh, Pennsylvania, 15243, United States

Location

Forest Investigative Site 1158

Upland, Pennsylvania, 19013, United States

Location

Forest Investigative Site 1089

East Providence, Rhode Island, 02914, United States

Location

Forest Investigative Site 1144

Johnston, Rhode Island, 02919, United States

Location

Forest Investigative Site 2072

Charleston, South Carolina, 29406, United States

Location

Forest Investigative Site 1078

Greenville, South Carolina, 29615, United States

Location

Forest Investigative Site 2080

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 1121

Spartanburg, South Carolina, 29303, United States

Location

Forest Investigative Site 1155

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 2012

Fort Worth, Texas, 76104, United States

Location

Forest Investigative Site 1165

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 1129

Waco, Texas, 76712, United States

Location

Forest Investigative Site 2099

Richmond, Virginia, 23225, United States

Location

Forest Investigative Site 1142

Spokane, Washington, 99204, United States

Location

Forest Investigative Site 0988

Tacoma, Washington, 98405, United States

Location

Forest Investigative Site 2201

Kelowna, British Columbia, V1Y 8E7, Canada

Location

Forest Investigative Site 1177

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Forest Investigative Site 2200

Niagara Falls, Ontario, L2g 1J4, Canada

Location

Forest Investigative Site 1168

Toronto, Ontario, M5G 1N8, Canada

Location

Forest Investigative Site 1171

Toronto, Ontario, M5T 3A9, Canada

Location

Forest Investigative Site 2203

Toronto, Ontario, M6H 3M2, Canada

Location

Related Publications (1)

• 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.

  PMID: 23679347 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 6, 2017
• Results First Posted: September 14, 2012

Record last verified: 2016-11

Locations

US (77); CA (6)