CHF1535 NEXT DPI
DrugFIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
NCT Number: NCT01191424
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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Notify Me12 year–65 year
All sexes
Interventional
Phase 2
Copenhagen University Hospital, Copenhagen, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
Time frame: 0-8hrs
Plasma AUC0-t for B17MP
Time frame: 0-8hrs
BDP/B17MP and FF PK parameters
Time frame: 0-8hrs
Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).
Time frame: 0-8hrs
Plasma Potassium Cmin, tmin and AUC0-t
Time frame: 0-8hrs
Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t
Time frame: 0-8hrs
time averaged value (AUC0-t/8)
Time frame: during the whole study period
Chiesi Farmaceutici S.p.A.
Industry
A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 Next™ DPI (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg) Versus the Free Combination of Licensed Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescents and Adult Patients
Acronym: ADONE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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