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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03817333
Eligibility Criteria:
Inclusion Criteria:
ALL SUBJECTS
1. Subjects aged 45 years and older.
2. Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
3. Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
4. Free of respiratory infection in the 4 weeks preceding the study.
5. No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
6. If female, not pregnant (or lactating).
7. Able to adhere to study procedures.
8. Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
ACOS SUBJECTS
1\. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
1. Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
2. With an IRAO.
Exclusion Criteria:
* ALL SUBJECTS
1. With COPD without a past diagnosis of asthma.
2. Unstable respiratory or non-respiratory condition.
3. Any active chronic inflammatory disease.
4. Any evidence of malignancy (active and/or treated) within the previous 5 years.
5. Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
6. Any history of bronchial thermoplasty. IRAO SUBJECTS
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1. Use of any nicotine containing product within 1 year prior to study entry or a smoking history of \> 5 pack-years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT03817333
Study Brief:
Protocol Section:
NCT03817333