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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT07011394
Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 6 to \<18 years, presenting symptoms suggestive of asthma
* Patients referred for a methacholine bronchial provocation test by primary care (defined as non-pulmonologist, non-ENT specialist, non-allergist)
* Spirometry inconclusive
Exclusion Criteria:
* Use of an inhaled or systemic corticosteroid in the previous 48 hours;
* Smoking in the previous 6 hours; history of viral and/or bacterial respiratory infection in the past 4 weeks;
* major cardiopulmonary disease, including: a) chronic obstructive pulmonary disease (COPD), defined by all of the following: i) aged ≥ 40 years , ii) permanent obstruction on spirometry (FEV1/FVC \<0.7) and iii) a smoking history of \>10 pack-years or known alpha-1-antitrypsin deficiency, b) lung conditions deemed significant by the investigator, including cystic fibrosis and bronchiectasis, and c) unstable heart disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT07011394
Study Brief:
Protocol Section:
NCT07011394