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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT03056066
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed consent.
2. Ageā„18 year.
3. Subject is cooperative and capable of following instructions.
4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
5. Phase II: Chronic pulmonary patients with lung volume disorders:
* COPD
* Asthma
* Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.
Exclusion Criteria:
1. Subjects unable or unwilling to give informed consent.
2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
3. History suggesting upper respiratory infection during the four weeks prior to testing
4. Physical activity during 1 hour prior to the Study.
5. Patients with a tracheostomy.
6. Pregnant women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03056066
Study Brief:
Protocol Section:
NCT03056066