A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: CHF1535 NEXThaler; Drug: CHF1535 pMDI; Drug: Placebo

• Registration Number: NCT03108534
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-28
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Primary Completion: 2017-09-19
• Study Completion: 2017-09-19
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Informed consent form obtained
• Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler
• Pre-bronchodilator FEV1 of at least 65%
• Positive response to methacholine challenge test
• Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines
• For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.

Exclusion Criteria

• Clinically relevant and uncontrolled concomitant diseases
• Abnormal clinically relevant ECG
• Presence of aortic aneurism
• Uncontrolled hypertension
• Intake of non-permitted concomitant medications
• Participation in another clinical trials in the previous 8 weeks
• Seasonal variation in asthma
• Recent occurrence of asthma exacerbations
• Hypersensitivity to any product used in the trial, including excipients
• Heavy caffeine drinkers
• History of alcohol/drug abuse
• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF1535 NEXThaler	CHF1535 NEXThaler	CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
CHF1535 pMDI	CHF1535 pMDI	CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)
Placebo	Placebo	Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler

Primary Outcome Measures

Name	Time	Method
Change in FEV1 5-min post-dose	5 min post-dose	Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)

Secondary Outcome Measures

Name	Time	Method
Change in FEV1 other time points	Up to 30 min post-dose	Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
FEV1 AUC0-10min	From dosing to 10 min post-dose	FEV1 area under the curve from dosing to 10 min post-dose
Change in Borg scale	Up to 30 min post-dose	Change in Borg scale from the end of the methacholine challenge test
Time to recovery in FEV1	From dosing to 30 min post-dose	Time to return to 85% of baseline value
Time to recovery in Borg scale	Up to 30 min post-dose	50% decrease from the post-methacholine challenge value

Trial Locations

Locations (3)

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

University of Dundee; 🇬🇧 Dundee, United Kingdom

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom