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

Study Identifier:
CCD-01535BD1-01
ClinicalTrials.gov Identifier:
NCT03108534
EudraCT Identifier:
2016-003672-47
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF1535 NEXThaler
  • Drug: CHF1535 pMDI
  • Drug: Placebo
Date
Feb 2017 - Sep 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion Criteria
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
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
University of Dundee
Dundee, United Kingdom
Status
N/A
Location
Hammersmith Medicines Research
London, United Kingdom
Status
N/A
Location
Medicines Evaluation Unit
Manchester, United Kingdom
Status
N/A