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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04134351
Eligibility Criteria:
Cases (asthmatics) inclusion criteria
1\. Physician diagnosed asthma, defined as a clear history of typical symptoms and clear reversibility of the PEF/FEV1 (12% or more) within the past year and/or methacholine PC20 \< 8mg/ml.
Cases Exclusion criteria
1. Pregnancy or lactation
2. Moderate / Severe asthma (FEV1/PEF \< 80%of the predicted value at screening)
3. Patients with any chronic illness other than asthma and other recognised atopic diseases (eczema, rhinitis) or any other abnormality which in the opinion of the principal investigator might compromise the study findings
4. A history of recent (within the past 4 weeks) upper or lower respiratory tract infection
5. Patients receiving oral, inhaled or parenteral glucocorticoid therapy (steroid) within the last 4 weeks, long acting relievers (salmeterol, formoterol) and antileukotrienes (montelukast) within last 72 hours.
6. Inadequate contraception in women of childbearing age
7. Inability to comprehend or comply with the protocol
Controls inclusion criteria
1\. Lifelong absence of asthma symptoms and lung function within the normal range.
Controls exclusion criteria
1. Pregnancy or lactation
2. Patients with any chronic illness or any other abnormality which in the opinion of the principal investigator might compromise the study findings
3. A history of recent (within the past 4 weeks) upper or lower respiratory tract infection
4. Oral, inhaled or parenteral glucocorticoid therapy (steroid) within the last 4 weeks, long acting relievers (salmeterol, formoterol) and antileukotrienes (montelukast) within last 72 hours
5. Inadequate contraception in women of childbearing age
6. Inability to comprehend or comply with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04134351
Study Brief:
Protocol Section:
NCT04134351