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The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
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| 2 | Active Comparator |
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| 3 | Active Comparator |
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| 4 | Active Comparator |
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| 5 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate, formoterol fumarate | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline | pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs | 10 weeks including pre- and post-study assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SKP | SkyePharma AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Belfast | Ireland | ||||
| Investigational site |
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| 6 | Active Comparator |
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| fluticasone propionate, formoterol fumarate | Drug |
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| fluticasone propionate, formoterol fumarate | Drug |
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| fluticasone propionate, formoterol fumarate | Drug |
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| fluticasone propionate, formoterol fumarate | Drug |
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| fluticasone propionate, formoterol fumarate | Drug |
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| Derbyshire |
| United Kingdom |
| Investigational site | London | United Kingdom |
| Investigational site | Manchester | United Kingdom |
| Investigational site | Plymouth | United Kingdom |
| Investigational site | Slough | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| C586520 | fluticasone-formoterol |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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