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Actual sample size of 156 was sufficient to estimate the clinical outcomes.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-daily aclidinium/formoterol | Experimental | Aclidinium 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 | Experimental | Aclidinium 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 Comparator | Formoterol fumarate 12 µg twice-daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once-daily aclidinium/formoterol | Drug | Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 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 | Week 4 of treatment |
| Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Tucson | Arizona | 85715 | United States | ||
| Forest Investigative Site |
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| Label | URL |
|---|---|
| lac-md-24-synopsis | View source |
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This study was conducted in 31 sites in the United States (US). All sites screened at least one patient and, of these 31 sites, three sites did not enroll any patients. The first patient was screened in March 2008 and the last patient visit was in February 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Once-daily Aclidinium/Formoterol | Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening |
| FG001 | Morning Aclidinium/Formoterol Plus Evening Formoterol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Twice-daily formoterol fumarate | Drug | Inhaled formoterol fumarate 12 µg twice-daily (BID) |
|
| Placebo to formoterol fumarate | Drug | Inhaled placebo to formoterol fumarate once-daily in the evening |
|
| Once-daily formoterol fumarate | Drug | Inhaled formoterol fumarate 12 μg once-daily in the evening |
|
| Week 4 of treatment |
| Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1) | FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose | Week 4 of treatment |
| 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 |
Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
| FG002 | Formoterol BID | Formoterol fumarate 12 μg twice-daily (BID) |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Once-daily Aclidinium/Formoterol | Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening |
| BG001 | Morning Aclidinium/Formoterol Plus Evening Formoterol | Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening |
| BG002 | Formoterol BID | Formoterol fumarate 12 μg twice-daily (BID) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study. | Posted | Mean | 95% Confidence Interval | Units on a scale | Week 4 of treatment |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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 | Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study. | Posted | Mean | 95% Confidence Interval | Units on a scale | Week 4 of treatment |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 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 | Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study. | Posted | Mean | 95% Confidence Interval | Liters | Week 4 of treatment |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study. | Posted | Mean | 95% Confidence Interval | Liters | Week 4 of treatment |
|
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| Other Pre-specified | Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1) | FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose | Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study. | Posted | Mean | 95% Confidence Interval | Liters | Week 4 of treatment |
|
29 ± 2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Once-daily Aclidinium/Formoterol | Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening | 1 | 63 | 0 | 63 | ||
| EG001 | Morning Aclidinium/Formoterol Plus Evening Formoterol | Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening | 1 | 62 | 0 | 62 | ||
| EG002 | Formoterol BID | Formoterol fumarate 12 μg twice-daily (BID) | 0 | 31 | 2 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v11 or newer | Systematic Assessment |
| |
| Drug withdrawal convulsions | Nervous system disorders | MedDRA v11 or newer | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v11 or newer | Systematic Assessment |
|
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
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Garcia | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Male |
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