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To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg |
|
| 2 | Active Comparator | CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg |
|
| 3 | Experimental | CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg |
|
| 4 | Active Comparator | CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP/Formoterol Next DPI | Drug | BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic | 3 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose FEV1 | every month | |
| Post-dose FEV1 AUC 0-8 h | 3 month period | |
| FVC and FEF 25-75% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oliver Kornmann - National Coordinator in Germany | Mainz | 55131 | Germany |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| Foster |
| Drug |
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg) |
|
| BDP/Formoterol Next DPI | Drug | BDP/Formoterol 100/6 µg (daily dose : 400/24 µg) |
|
| Foster | Drug | BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg) |
|
| every month |
| PEF | every day |
| Morning and evening asthma clinical symptoms scores | every day |
| Moderate and severe exacerbations | every month |
| Rescue medication | every day |
| Sputum | 3 month period |
| 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 |
|---|---|
| D005581 | Foster Home Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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