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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT02123667
Eligibility Criteria:
Asthmatic patient inclusion criteria
1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form
2. Clinical diagnosis of asthma f
1. Positive response to methacholine challenge test
2. Positive response to a reversibility test or
3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or
4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.
3. Patients with stable asthma.
4. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria
1\. Male or female patients aged ≥ 18 and ≤ 65 years 2. No clinical history of asthma or COPD 3. Current smoker, ex-smoker or lifelong non-smokers 4. Normal spirometry 5. Normal airways responsiveness Asthmatic patient exclusion criteria
1. Cigarette smoking \> 10 packyears
2. diagnosis of COPD
3. Asthma exacerbation in the 8 weeks prior to baseline visit
4. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study.
5. Pregnant or lactating women
6. Participation in an interventional clinical trial \<12 weeks preceding baseline visit
7. Inability to comply with study procedures.
8. Alcohol or drug abuse. Healthy subject exclusion criteria
1\. Cigarette smoking history \> 10 packyears 2. Diagnosed upper and/or lower respiratory disease(s). 3. Clinical or functional uncontrolled haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that mightp compromise the results or interpretation of the study.
4\. Pregnant or lactating women 5. Participation in an interventional clinical trial \<12 weeks preceding baseline visit 6. Inability to comply with study procedures. 7. Alcohol or drug abuse.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02123667
Study Brief:
Protocol Section:
NCT02123667