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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018947-33 | EudraCT Number |
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The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF1535 NEXT DPI | Experimental | Male and female adolescents and adult patients (≥ 12 years old) treated with CHF1535 NEXT DPI |
|
| Free combination BDP and FF | Active Comparator | Male and female adolescents and adult patients (≥ 12 years old) treated with a free combination of licenced BDP and FF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF1535 NEXT DPI | Drug | FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI | Plasma AUC0-t for B17MP | 0-8hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Different pharmacokinetic parameters | BDP/B17MP and FF PK parameters | 0-8hrs |
| Lung function parameters | Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicines Evaluation Unit | Study Director |
| Hans Bisgaard, MD | Copenhagen University Hospital at Herlev | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Copenhagen | 2800 | Denmark | |||
| Medicines Evaluation Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24746942 | Background | Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16. | |
| 24830339 |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| BDP DPI and formoterol DPI | Drug | FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI |
|
| 0-8hrs |
| Plasma potassium | Plasma Potassium Cmin, tmin and AUC0-t | 0-8hrs |
| Plasma glucose | Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t | 0-8hrs |
| Heart rate | time averaged value (AUC0-t/8) | 0-8hrs |
| Adverse Events | during the whole study period |
| Manchester |
| M23 9QZ |
| United Kingdom |
| Chawes BL, Govoni M, Piccinno A, Kreiner-Moller E, Vissing NH, Mortensen L, Nilsson E, Bisgaard A, Deleuran M, Skytt N, Samandari N, Acerbi D, Bisgaard H. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014 Nov;78(5):1169-71. doi: 10.1111/bcp.12424. No abstract available. |
| 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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