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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT04743206
Eligibility Criteria:
Inclusion Criteria:
* Ages 6-21 years
* Cystic fibrosis stable by physician assessment
* Assents to forego additional experimental treatments during the study
* Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
* Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----Informed Consent
Exclusion Criteria:
* FEV1 \< 40% predictive
* Pneumothorax
* Hemoptysis
* Coronavirus disease (COVID) 19 diagnosis within last 14 days
* Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
* Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 \> 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation
* Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 \> 10 % from initial Pulmonary function testing (PFTs) on admission by day 9 of hospitalization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT04743206
Study Brief:
Protocol Section:
NCT04743206