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This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reference treatment | Active Comparator | Free combination of Beclomethasone dipropionate DPI and Formoterol fumarate DPI |
|
| CHF 1535 NEXT DPI | Experimental | CHF 1535 50/6 NEXT DPI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| free comb. beclomethasone DPI and formoterol DPI | Drug | free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug). |
| Measure | Description | Time Frame |
|---|---|---|
| B17MP (active metabolite of BDP) Area Under Curve (AUC) | B17MP: Profile of Pharmacokinetics | predose, 15,30min, 1,2,4,6,8 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| B17MP Cmax,Tmax,T1/2 | BDP: profile of pharmacokinetics. | predose, 15min,30min,1,2,4,6,8 hours post dose |
| BDP Area Under Curve (AUC), Cmax, Tmax, T1/2 | BDP: profile of Pharmacokinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Bisgaard | BorneAstmaKlinikken, Copenaghen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BørneAstmaKlinikken, Hans Knudsens Plads 1A, | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24993817 | Result | Chawes BL, Govoni M, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilsson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Piccinno A, Sergio F, Ciurlia G, Poli G, Acerbi D, Singh D, Bisgaard H. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014 Aug;108(8):1108-16. doi: 10.1016/j.rmed.2014.05.007. Epub 2014 Jun 17. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| CHF 1535 50/6 NEXT DPI | Drug | four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug) |
|
| predose, 15min,30min,1,2,4,6,8 hours postdose |
| Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 | Formoterol: profile of pharmacokinetics | predose, 15min, 30 min, 1,2,4,6,8 hours postdose |
| plasma potassium Area Under Curve (AUC), Cmin, Tmin | plasma potassium to evaluate drug systemic effect | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose |
| Heart Rate: Time averaged Heart Rate value: AUC0-t/t | Heart Rate to evaluate drug systemic effect | predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose |
| Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat). | Urinary cortisol to evaluate drug systemic effect | from predose up to 8 hours postdose |