Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Interventions: Drug: Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium

• Registration Number: NCT02975843
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF 5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-15
• Study Start: 2016-11-21
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Primary Completion: 2017-03-21
• Study Completion: 2017-04-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHF5993	Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium	99mTc Radiolabelled Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI

Primary Outcome Measures

Name	Time	Method
Intrapulmonary Lung deposition expressed as % of nominal dose	Immediately after dosing	Calculated using the individual Gamma camera images

Secondary Outcome Measures

Name	Time	Method
Distribution of lung deposition	Immediately after dosing	Calculated using the individual Gamma camera images
BDP/B17MP, Formoterol, and GB Peak Plasma Concentration (Cmax)	the value of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h	Calculated through plasma samples for PK evaluation
BDP/B17MP, Formoterol, and GB tmax	time of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h	Calculated through plasma samples for PK evaluation
Extrathoracic deposition	Immediately after dosing	Calculated using the individual Gamma camera images
Exhaled activity	Immediately after dosing	Calculated using the individual Gamma camera images
BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-t	the area under the plasma concentration-time curve from 0 to the last quantifiable concentration. Over 24h	Calculated through plasma samples for PK evaluation
BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-30min	area under the plasma concentration-time curve from 0 to 30 min post-dose	Calculated through plasma samples for PK evaluation
BDP/B17MP, Formoterol, and GB area under the curve (AUC) 0-∞	area under the curve extrapolated to infinity over 24h	Calculated through plasma samples for PK evaluation
BDP/B17MP, Formoterol, and GB t½	the terminal (apparent elimination) half-life over 24h	Calculated through plasma samples for PK evaluation
lung function assessment	Over 24 h post dose	Calculated using spirometry