Back to resultsComparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Once-daily aclidinium/formoterol
Twice-daily formoterol fumarate
Placebo to formoterol fumarate
Once-daily formoterol fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Forest Investigative Site
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- Forest Investigative Site
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- Forest Investigative Site
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- Forest Investigative Site
- Forest Investigative Site
- Forest Investigative Site
- Forest Investigative Site
- Forest Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Once-daily aclidinium/formoterol
Morning aclidinium/formoterol plus evening formoterol
Formoterol BID
Arm Description
Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Formoterol fumarate 12 µg twice-daily (BID)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00706914
Brief Title
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Actual sample size of 156 was sufficient to estimate the clinical outcomes.
Study Start Date
June 30, 2008 (Actual)
Primary Completion Date
November 11, 2008 (Actual)
Study Completion Date
November 11, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Once-daily aclidinium/formoterol
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Arm Title
Morning aclidinium/formoterol plus evening formoterol
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Arm Title
Formoterol BID
Arm Type
Active Comparator
Arm Description
Formoterol fumarate 12 µg twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
Once-daily aclidinium/formoterol
Intervention Description
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Intervention Type
Drug
Intervention Name(s)
Twice-daily formoterol fumarate
Intervention Description
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo to formoterol fumarate
Intervention Description
Inhaled placebo to formoterol fumarate once-daily in the evening
Intervention Type
Drug
Intervention Name(s)
Once-daily formoterol fumarate
Intervention Description
Inhaled formoterol fumarate 12 μg once-daily in the evening
Primary Outcome Measure Information:
Title
Change From Baseline in Weekly Average Nocturnal Symptom Scores
Description
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
Time Frame
Week 4 of treatment
Title
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Description
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Time Frame
Week 4 of treatment
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Description
The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day
Time Frame
Week 4 of treatment
Title
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Time Frame
Week 4 of treatment
Title
Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)
Description
FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose
Time Frame
Week 4 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Forest Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Forest Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Forest Investigative Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Forest Investigative Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forest Investigative Site
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Forest Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Forest Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Forest Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Forest Investigative Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Forest Investigative Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Facility Name
Forest Investigative Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Forest Investigative Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Forest Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Forest Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Forest Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Forest Investigative Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Forest Investigative Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Forest Investigative Site
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Forest Investigative Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Forest Investigative Site
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
Forest Investigative Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Forest Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Forest Investigative Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Forest Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Forest Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Forest Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Forest Investigative Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Forest Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Forest Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Forest Investigative Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Forest Investigative Site
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
Country
United States
Facility Name
Forest Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Forest Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4065&filename=lac-md-24-synopsis.pdf
Description
lac-md-24-synopsis
Learn more about this trial
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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