Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01803087
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2012-10-04
Brief Title:
Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
A SINGLE-DOSE OPEN LABEL RANDOMIZED 3-WAY CROSSOVER CLINICAL PHARMACOLOGY STUDY OF CHF 1535 1006 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 1006 pMDI
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADO pMDI
Brief Summary:
This clinical pharmacology want to investigate the systemic availability of BDPB17MP active metabolite of BDP and formoterol after single oral inhalation of CHF 1535 1006 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 BDPB17MP active metabolite of BDP and formoterol after single oral inhalation of CHF 1535 1006 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 BDPB17MP 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
The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None