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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1; Drug: CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).; Drug: CHF 1535 100/6 pMDI (Foster®) (CTR); Drug: BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)

• Registration Number: NCT01803087
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief 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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 1535 100/6 pMDI (Foster®) TEST 1	Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1	Adolescents CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
CHF 1535 100/6 pMDI (Foster®) AeroChamber Plus™ (TEST 2).	CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).	CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ spacer device in adolescents (TEST 2)
CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI	CHF 1535 100/6 pMDI (Foster®) (CTR)	Adults CHF 1535 100/6, 4 puffs (total dose: BDP 400 µg/FF 24 µg) pMDI
(Qvar®: BDP 400 µg)+(Atimos®: formoterol 24 µg)	BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)	BDP 100 µg pMDI, 4 puffs (Qvar®, total dose: BDP 400 µg) + formoterol fumarate 6 µg pMDI, 4 puffs (Atimos®, total dose: formoterol 24 µg)

Primary Outcome Measures

Name	Time	Method
AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI	: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, the systemic exposure of B17MP as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) vs already licensed free combination of BDP pMDI and formoterol pMDI without spacer.

Secondary Outcome Measures

Name	Time	Method
AUC0-t, AUC0-inf, Cmax, tmax and t½ for BDP and formoterol	: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.
AUC0-0.5h, AUC0-inf, Cmax, tmax and t½ for B17MP	: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.
plasma glucose and plasma potassium AUC0-t; Cmin; Tmin; Cmax; Tmax	: pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, after inhalation of CHF 1535 100/6 pMDI with and without spacer (AeroChamber Plus™)vs fre combination
Heart rate as AUC0-8h of CHF 1535 100/6 pMDI	pre-dose (within 5 min from dosing), 5 min; 10 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs free combination
FEV1; time everaged FEV1 value AUC0-8h; peak FEV1	pre-dose; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.	In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.

Trial Locations

Locations (1)

Uniwersytecki Szpital Kliniczny nr 1; 🇵🇱 Lodz, Poland