A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00500318 | Completed Phase 3 Results

• 1 other identifier: LAS-MD-CL26
• Study Type: interventional
• Target: 181
• Locations: 2 countries
• Sites: 52

Brief Summary

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Bronchitis, Chronic; Emphysema

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Exercise Endurance Time (ET)

  Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.

  From baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Secondary Outcomes (4)

• Trough Forced Expiratory Volume in 1 Second (FEV1)

  Change from baseline (Visit 4) at Week 6 (Visit 6)

• Trough Inspiratory Capacity (IC)

  Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

• Functional Residual Capacity (FRC)

  Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

• Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio

  Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Study Arms (2)

Aclidinium

EXPERIMENTAL

Drug: Aclidinium Bromide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aclidinium Bromide DRUG

Aclidinium Bromide, 200μg. Once daily oral inhalation.

Aclidinium

Placebo DRUG

Dose matched placebo, once daily oral inhalation.

Placebo

Eligibility Criteria

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

You may qualify if:

• A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 \>=30% and \< 80% predicted and FEV1/FVC\<70% predicted
• Current or former cigarette smoker
• Functional Residual Capacity (FRC) measured by body plethysmography \>= 120% of predicted value
• Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

You may not qualify if:

• History of presence of asthma, allergic rhinitis, or atopy
• Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
• Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
• Clinically significant respiratory conditions other than COPD
• Chronic use of oxygen therapy \>= 15 hours a day

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (52)

Forest Investigative Site 2088

Jasper, Alabama, 35501, United States

Location

Forest Investigative Site 0909

Phoenix, Arizona, 85006, United States

Location

Forest Investigative Site 0957

Long Beach, California, 90822, United States

Location

Forest Investigative Site 0973

Los Angeles, California, 90073, United States

Location

Forest Investigative Site 0887

Los Angeles, California, 90095-1690, United States

Location

Forest Investigative Site 0988

Sacramento, California, 95817, United States

Location

Forest Investigative Site 0885

Torrance, California, 90502, United States

Location

Forest Investigative Site 2663

Clearwater, Florida, 33756, United States

Location

Forest Investigative Site 1030

Jacksonville, Florida, 32224, United States

Location

Forest Investigative Site 0974

Pensacola, Florida, 32504, United States

Location

Forest Investigative Site 0980

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 0991

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 0987

Austell, Georgia, 30106, United States

Location

Forest Investigative Site 2008

Marietta, Georgia, 30060, United States

Location

Forest Investigative Site 0984

Iowa City, Iowa, 52242, United States

Location

Forest Investigative Site 1080

Topeka, Kansas, 66606, United States

Location

Forest Investigative Site 0898

Baltimore, Maryland, 21224, United States

Location

Forest Investigative Site 0886

Boston, Massachusetts, 02135, United States

Location

Forest Investigative Site 1029

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 0889

Livonia, Michigan, 48152, United States

Location

Forest Investigative Site 2079

Saint Charles, Missouri, 63301, United States

Location

Forest Investigative Site 2071

Omaha, Nebraska, 68198-2465, United States

Location

Forest Investigative Site 0972

Brooklyn, New York, 11229, United States

Location

Forest Investigative Site 0971

Great Neck, New York, 11023, United States

Location

Forest Investigative Site 1114

New York, New York, 10001, United States

Location

Forest Investigative Site 2665

New York, New York, 10010-7436, United States

Location

Forest Investigative Site 2081

Charlotte, North Carolina, 28207, United States

Location

Forest Investigative Site 0688

Charlotte, North Carolina, 28262, United States

Location

Forest Investigative Site 0981

Toledo, Ohio, 43614, United States

Location

Forest Investigative Site 1057

Hershey, Pennsylvania, 17033, United States

Location

Forest Investigative Site 0888

Philadelphia, Pennsylvania, 19140, United States

Location

Forest Investigative Site 0983

Scranton, Pennsylvania, 18509, United States

Location

Forest Investigative Site 2072

Charleston, South Carolina, 29406, United States

Location

Forest Investigative Site 1107

Columbia, South Carolina, 29201, United States

Location

Forest Investigative Site 0979

Columbia, South Carolina, 29203, United States

Location

Forest Investigative Site 1078

Greenville, South Carolina, 29615, United States

Location

Forest Investigative Site 0900

Spartanburg, South Carolina, 29303, United States

Location

Forest Investigative Site 0962

Nashville, Tennessee, 37232-2650, United States

Location

Forest Investigative Site 1082

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 2058

Dallas, Texas, 75246, United States

Location

Forest Investigative Site 0890

Houston, Texas, 77030, United States

Location

Forest Investigative Site 0977

Midvale, Utah, 84047, United States

Location

Forest Investigative Site 0968

Edmonton, Alberta, T6G 2B7, Canada

Location

Forest Investigative Site 0960

Kelowna, British Columbia, V1Y 1E4, Canada

Location

Forest Investigative Site 0905

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Forest Investigative Site 0976

Winnipeg, Manitoba, R2K 3S8, Canada

Location

Forest Investigative Site 0891

Hamilton, Ontario, L8N 3Z5, Canada

Location

Forest Investigative Site 2204

Ottawa, Ontario, K1Y4E9, Canada

Location

Forest Investigative Site 0969

Windsor, Ontario, N8X 3V6, Canada

Location

Forest Investigative Site 2205

Montreal, Quebec, H4J 1C5, Canada

Location

Forest Investigative Site 0893

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Forest Investigative Site 0943

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.

  PMID: 21183326 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchiolitis Obliterans Syndrome; 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; Respiratory Tract Infections; Infections; Bronchial Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Graft vs Host Disease; Immune System 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: September 1, 2010
• Last Updated: January 6, 2017
• Results First Posted: December 17, 2012

Record last verified: 2016-11

Locations

US (42); CA (10)