NCT06900816

A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001

A Single-centre, Single-dose, Open Label, Non-randomized, Parallel Group, Clinical Pharmacology Study of CHF 6001 in Asthmatic Adolescent Patients and in Asthmatic Adult Patients as Control Group

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.

Detailed description

The study plan foresees a total of four visits at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be trained to assess their ability to use an inhaler device and to teach the inhaling technique. At the following visit, the patients will inhale through the device and amount of the study drug and of its metabolites in the blood will be measured at different times after inhalation. At a subsequent ambulatory visit, the final measurements will be performed. A follow-up Visit will be done to check patients safety and wellbeing, 12 to 14 days after the study treatment intake. A total of 25 asthmatic adults (≥18 years), and 25 asthmatic adolescents ( ≥12 and \<18 years) with a stable asthma therapy according to international guidelines Global Initiative for Asthma (GINA) (update 2024), will be enrolled.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 6001	CHF 6001 DPI single dose
DRUG	CHF 6001	CHF 6001 DPI single dose

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2025-03-28
• Last updated: 2025-11-26

Locations

1 site across 1 country: Bulgaria