NCT01803087

Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients

A SINGLE-DOSE, OPEN LABEL, RANDOMIZED, 3-WAY CROSSOVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 100/6 pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg) WITH OR WITHOUT SPACER DEVICE VERSUS THE FREE COMBINATION OF LICENSED BECLOMETHASONE pMDI AND FORMOTEROL pMDI IN ASTHMATIC ADOLESCENT PATIENTS AND ONE OPEN ARM FOR ADULT PATIENTS AS CONTROL GROUP TREATED WITH CHF 1535 100/6 pMDI.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.

Detailed description

The proposed clinical pharmacology study is aimed to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic exposure in adults without the spacer device. The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1
DRUG	CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).
DRUG	BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)
DRUG	CHF 1535 100/6 pMDI (Foster®) (CTR)

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-03-04
• Last updated: 2020-07-31

Locations

1 site across 1 country: Poland