Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

COPD Clinical Trial

— TRIPLE 4  

Official title:

Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119234
• Other study ID #: CCD-05993AA1-04
• Secondary ID: 2013-003770-27
• Status: Completed
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Beclometasone/formoterol/glycopyrrolate

• Placebo

Locations

Country	Name	City	State
Poland	Medical University in Lodz	Lodz	Ul. Kopcinskiego 22

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of B17MP, formoterol and glycopyrrolate	AUCt (up to the last quantifiable concentration) and Cmax (maximum concentration) from plasma concentrations vs time profiles.; over 24h for formoterol and B17MP, over 48h for glycopyrrolate	Over 24 and 48h after single administration
Secondary	Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma	B17MP AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Formoterol AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Glycopyrrolate AUC0-30min, AUC0-48h, AUCinf, tmax, half-life	over 24 or 48h after single administration
Secondary	Adverse events	from the signature of the informed consent until the follow-up phone call	over a period of 6 to 11 weeks
Secondary	Lung function	FEV1	30 min after single administration
Secondary	plasma cortisol	cortisol AUC0-24h, Cmin and tmin	over 24 h after single administration
Secondary	cortisol urinary excretion	cortisol excretion corrected and not corrected for creatinine	over 24 h after single administration
Secondary	potassium plasma profile	potassium AUC0-24h, tmin and Cmin	over 24 h after single administration
Secondary	Vital signs	systolic and diastolic blood pressure	over 24 h after single administration
Secondary	ECG parameters	extracted from holter recording HR, QTcF, PR and QRS	over 24 h after single administration

External Links

•   CSR Synopsis available in the Chiesi Clinical Study Register