A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.

NCT01738087 Phase 2 COMPLETED

The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 2
Status	COMPLETED
Enrolment	30
Start date	2012-11
Completion	2013-01

Conditions

• Asthmatic

Interventions

• NEXThaler 100/6 mcg DPI
• Flixotide Accuhaler 500 mcg
• NEXThaler 200/6 mcg DPI
• NEXThaler placebo

Primary outcomes

• Formoterol AUC0-t and B17MP AUC0-t — from predose until 12 hr post dose

Countries

United Kingdom