Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT03108534
Eligibility 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:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03108534
Study Brief:
Protocol Section:
NCT03108534