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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT03681093
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score \>= 4 with minimum score of 2 in each nostril.
* Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
* Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.
Exclusion Criteria:
* Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
* Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
* Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
* Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
* Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
* History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
* Patients with baseline ACQ-5≥1.5
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03681093
Study Brief:
Protocol Section:
NCT03681093