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A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children (PAED1)
The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
Details
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2009-09 |
| Completion | 2010-12 |
Conditions
- Asthma
Interventions
- CHF1535 pMDI + AC Plus
- BDP + AC Plus
- Formoterol + AC Plus
Primary outcomes
- B17MP AUC0-t — pre-dose until 8hours post dose
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
Countries
Denmark