Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
