Study Stopped
Actual sample size of 156 was sufficient to estimate the clinical outcomes.
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily
1 other identifier
interventional
156
1 country
40
Brief Summary
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedStudy Start
First participant enrolled
June 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2008
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedMay 15, 2017
April 1, 2017
4 months
June 26, 2008
February 3, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Weekly Average Nocturnal Symptom Scores
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Week 4 of treatment
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Week 4 of treatment
Other Outcomes (3)
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Week 4 of treatment
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Week 4 of treatment
Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)
Week 4 of treatment
Study Arms (3)
Once-daily aclidinium/formoterol
EXPERIMENTALAclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Morning aclidinium/formoterol plus evening formoterol
EXPERIMENTALAclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Formoterol BID
ACTIVE COMPARATORFormoterol fumarate 12 µg twice-daily (BID)
Interventions
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Inhaled placebo to formoterol fumarate once-daily in the evening
Inhaled formoterol fumarate 12 μg once-daily in the evening
Eligibility Criteria
You may qualify if:
- Moderate to severe COPD
- Smoking history of greater or equal to 10 pack-years
- Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
- Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
- Postbronchodilator FEV1/FVC ratio \< 0.70
You may not qualify if:
- History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
- Hospitalization for an 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
- Eosinophil count of at least 600 cells/mm3
- Long term oxygen therapy \> 15 hours a day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Forest Investigative Site
Tucson, Arizona, 85715, United States
Forest Investigative Site
Tucson, Arizona, 85741, United States
Forest Investigative Site
Fullerton, California, 92835, United States
Forest Investigative Site
Lakewood, California, 90712, United States
Forest Investigative Site
Rancho Mirage, California, 92270, United States
Forest Investigative Site
Redlands, California, 92373, United States
Forest Investigative Site
San Diego, California, 92120, United States
Forest Investigative Site
San Jose, California, 95124, United States
Forest Investigative Site
Stockton, California, 95207, United States
Forest Investigative Site
Wheat Ridge, Colorado, 80033, United States
Forest Investigative Site
Hartford, Connecticut, 06105, United States
Forest Investigative Site
New Britain, Connecticut, 06053, United States
Forest Investigative Site
Waterbury, Connecticut, 06708, United States
Forest Investigative Site
DeLand, Florida, 32720, United States
Forest Investigative Site
Panama City, Florida, 32405, United States
Forest Investigative Site
Tamarac, Florida, 33321, United States
Forest Investigative Site
Tampa, Florida, 33603, United States
Forest Investigative Site
Atlanta, Georgia, 30342, United States
Forest Investigative Site
Austell, Georgia, 30106, United States
Forest Investigative Site
Blue Ridge, Georgia, 30513, United States
Forest Investigative Site
Bowling Green, Kentucky, 42101, United States
Forest Investigative Site
Hazard, Kentucky, 41701, United States
Forest Investigative Site
North Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site
Rochester, Minnesota, 55905, United States
Forest Investigative Site
Florissant, Missouri, 63033, United States
Forest Investigative Site
Saint Charles, Missouri, 63301, United States
Forest Investigative Site
St Louis, Missouri, 63110, United States
Forest Investigative Site
Albany, New York, 12205, United States
Forest Investigative Site
Charlotte, North Carolina, 28207, United States
Forest Investigative Site
Cincinnati, Ohio, 45242, United States
Forest Investigative Site
Columbus, Ohio, 43215, United States
Forest Investigative Site
Medford, Oregon, 97504, United States
Forest Investigative Site
Pittsburgh, Pennsylvania, 15213, United States
Forest Investigative Site
East Providence, Rhode Island, 02914, United States
Forest Investigative Site
Spartanburg, South Carolina, 29303, United States
Forest Investigative Site
Dallas, Texas, 75246, United States
Forest Investigative Site
McKinney, Texas, 75069, United States
Forest Investigative Site
Midvale, Utah, 84047, United States
Forest Investigative Site
Richmond, Virginia, 23225, United States
Forest Investigative Site
Milwaukee, Wisconsin, 53209, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to early termination of the study, the actual sample size is different from the study design (200 patients) Actual sample size was 156, but because this was an exploratory study, this was considered sufficient to estimate the clinical outcomes
Results Point of Contact
- Title
- Esther Garcia
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Esther Garcia, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
June 30, 2008
Primary Completion
November 11, 2008
Study Completion
November 11, 2008
Last Updated
May 15, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-04