NCT03084718

An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (pMDI) on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.

Detailed description

This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect to lung function and other clinical efficacy and safety outcomes. After a 2 week run-in period under rescue albuterol as needed and background inhaled corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups. After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the center. A follow-up phone call will be performed a week after the last visit. During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication will be recorded via subject diary. Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study. At screening and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry, and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine cortisol and creatinine will be assessed before and after the first dose and just before the last dose of study treatment.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 718 pMDI	Dose Response: Test one of three different doses of CHF 718 pMDI
DRUG	Placebo pMDI	Placebo Control
DRUG	Beclomethasone Dipropionate (BDP)	Active Control

Timeline

• Start date: 2017-07-28
• Primary completion: 2018-11-28
• Completion: 2018-12-05
• First posted: 2017-03-21
• Last updated: 2021-12-14
• Results posted: 2021-12-14

Locations

134 sites across 1 country: United States

Regulatory

• FDA-regulated drug study