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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02188758
Eligibility Criteria:
Inclusion Criteria (required at screening visit):
* Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;
* History of consistent sputum production on most occasions;
* FEV1% greater than or equal to 75% of best measurement in previous 6 months;
* 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
* Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score \<5);
* Not admitted to hospital within the previous 3 weeks;
* Body weight greater than or equal to 75% of best measurement in previous 6 months;
* Provision of signed informed-consent to study protocol;
* 18\<Age\>65
Exclusion Criteria:
* Women who are pregnant or lactating;
* Subject does not meet Inclusion criteria;
* Recent and/or persistent visible blood in sputum (hemoptysis);
* Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02188758
Study Brief:
Protocol Section:
NCT02188758