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

A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: CHF1535 NEXThaler; Drug: CHF1535 pMDI; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom
    • University of Dundee
  • London, United Kingdom
    • Hammersmith Medicines Research
  • Manchester, United Kingdom
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF1535 NEXThaler; CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)	Drug: CHF1535 NEXThaler; Rescue treatment; Other Names: Foster NEXThaler
Active Comparator: CHF1535 pMDI; CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)	Drug: CHF1535 pMDI; Rescue treatment; Other Names: Foster
Placebo Comparator: Placebo; Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler	Drug: Placebo; Rescue treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 5-min post-dose	Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)	5 min post-dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): September 19, 2017
• Study Completion (Actual): September 19, 2017

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CCD-01535BD1-01; 2016-003672-47 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No