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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT03758950
Eligibility Criteria:
Inclusion Criteria:
* Participants age 18 and older with severe SCD phenotypes (Hb SS and Sβthalassemia0):
* Do not have asthma (see exclusion criteria)
* Not currently having a painful crisis (as defined by validated pain diary questions)
* Do not have acute respiratory symptoms
* Report of recent ECW (answers "Yes" to any question in Box 1)
* Participant is already medically optimized (i.e. already on maximum dose hydroxyurea unless contraindicated and not undergoing medication titration).
Exclusion Criteria:
* Participant screens positive for possible undiagnosed asthma (Box 2)
* Pregnant or planning to become pregnant
* \> 15 ED visits for SCD pain over the previous 12 months (due to concern for multi-factorial pain that may be less responsive to SCD therapies)
* Have been discharged from the hospital within the previous 7 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03758950
Study Brief:
Protocol Section:
NCT03758950