Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients (TRIPLE 4)

Chiesi

Status and phase

Completed

Phase 1

Conditions

COPD

Treatments

Drug: Beclometasone/formoterol/glycopyrrolate

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02119234

CCD-05993AA1-04

2013-003770-27 (EudraCT Number)

Details and patient eligibility

About

The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.

Enrollment

36 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

COPD patients
smokers or ex-smokers
post-bronchodilator FEV1 between 30 and 60% of predicted value

Exclusion criteria

Positive serology to HIV and hepatitis
Known respiratory disorder other than COPD
Recent COPD exacerbations or hospitalization for COPD
Treatment with non-permitted concomitant medication
clinically relevant concomitant disease
clinically relevant abnormal laboratory or ECG parameters

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

36 participants in 3 patient groups, including a placebo group

CHF5993 pMDI + Spacer

Experimental group

Description:

CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer

Treatment:

Drug: Beclometasone/formoterol/glycopyrrolate

CHF5993 pMDI

Active Comparator group

Description:

CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only

Treatment:

Drug: Beclometasone/formoterol/glycopyrrolate

Placebo pMDI

Placebo Comparator group

Description:

Placebo pMDI x 4 inhalations