Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium/formoterol 400/12μg FDC | Experimental | Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
|
| Formoterol | Active Comparator | Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium/formoterol 400/12μg | Drug | Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State | The standard deviation of the measure is expressed as the coefficient of variation (%) | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose) |
| Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State | The standard deviation of the measure is expressed as the coefficient of variation (%) | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose) |
| Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose | The standard deviation of the measure is expressed as the coefficient of variation (%) | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose | The standard deviation of the measure is expressed as the coefficient of variation (%) | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 001 | Spartanburg | South Carolina | 29303 | United States |
Not provided
| Label | URL |
|---|---|
| CSR Synopsis | View source |
Not provided
Not provided
The study was conducted in a single center in the United States
First patient visit was in January 2012 and last patient visit was in March 2012
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Formoterol | Drug | Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
|
|
| FG001 |
| Sequence 2 |
Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All patients participating in the crossover study |
| 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 |
| |||||||||||||||||
| Gender | 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 | Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State | The standard deviation of the measure is expressed as the coefficient of variation (%) | The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters | Posted | Mean | Standard Deviation | pg*hr/mL | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State | The standard deviation of the measure is expressed as the coefficient of variation (%) | The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters | Posted | Mean | Standard Deviation | pg/mL | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose | The standard deviation of the measure is expressed as the coefficient of variation (%) | The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters | Posted | Mean | Standard Deviation | pg*hr/mL | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose |
|
| |||||||||||||||||||||||||||||
| Primary | Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose | The standard deviation of the measure is expressed as the coefficient of variation (%) | The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters | Posted | Mean | Standard Deviation | pg/mL | Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose |
|
|
Up to study Day 17
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aclidinium/Formoterol 400/12 μg | Fixed dose combination (FDC) administered via Almirall inhaler | 0 | 24 | 0 | 24 | ||
| EG001 | Formoterol 12 μg | Administered via Foradil® Aerolizer® | 2 | 24 | 0 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA v15.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA v15.0 | Systematic Assessment |
|
Not provided
Publication of the results by the PI will be subject to mutual agreement between the PI and sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| 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 |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided
|
|
|