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

NCT02119234 | Completed Phase 1

• 2 other identifiers: CCD-05993AA1-042013-003770-27
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma

  over 24 or 48h after single administration

• Adverse events

  over a period of 6 to 11 weeks

• Lung function

  30 min after single administration

• plasma cortisol

  over 24 h after single administration

• cortisol urinary excretion

  over 24 h after single administration

Study Arms (3)

CHF5993 pMDI + Spacer

EXPERIMENTAL

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

CHF5993 pMDI

ACTIVE COMPARATOR

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

Drug: Beclometasone/formoterol/glycopyrrolate

Placebo pMDI

PLACEBO COMPARATOR

Placebo pMDI x 4 inhalations

Drug: Placebo

Interventions

Beclometasone/formoterol/glycopyrrolate DRUG

Also known as: CHF5993 pMDI

CHF5993 pMDI; CHF5993 pMDI + Spacer

Placebo DRUG

Placebo pMDI

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Medical University in Lodz

Lodz, Ul. Kopcińskiego 22, 90-153, Poland

Location

Related Links

• CSR Synopsis available in the Chiesi Clinical Study Register

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Piotr Kuna, MD

  Medical University Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

PL (1)