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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Placebo; Drug: Beclometasone/formoterol/glycopyrrolate

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Ul. Kopcińskiego 22
    • Lodz, Ul. Kopcińskiego 22, Poland, 90-153
      • Medical University in Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF5993 pMDI + Spacer; CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer	Drug: Beclometasone/formoterol/glycopyrrolate; Other Names: CHF5993 pMDI
Active Comparator: CHF5993 pMDI; CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only	Drug: Beclometasone/formoterol/glycopyrrolate; Other Names: CHF5993 pMDI
Placebo Comparator: Placebo pMDI; Placebo pMDI x 4 inhalations	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs	systolic and diastolic blood pressure	over 24 h after single administration
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
Adverse events	from the signature of the informed consent until the follow-up phone call	over a period of 6 to 11 weeks
Lung function	FEV1	30 min after single administration
plasma cortisol	cortisol AUC0-24h, Cmin and tmin	over 24 h after single administration
cortisol urinary excretion	cortisol excretion corrected and not corrected for creatinine	over 24 h after single administration
potassium plasma profile	potassium AUC0-24h, tmin and Cmin	over 24 h after single administration
ECG parameters	extracted from holter recording HR, QTcF, PR and QRS	over 24 h after single administration

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Piotr Kuna, MD, Medical University Lodz

Publications and helpful links

Helpful Links

• CSR Synopsis available in the Chiesi Clinical Study Register

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: CCD-05993AA1-04; 2013-003770-27 (EudraCT Number)