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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT01840735
Eligibility Criteria:
Inclusion Criteria:
* Males or females, ≥ 18 years of age, at Screening
* Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepithelial potential difference (NPD) test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND 1 or more accompanying clinical features consistent with CF
* FEV1 ≥ 40% and ≤ 90% predicted
* BMI ≥ 19 and ≤ 30 kg/m2
* Clinically stable with no evidence of significant new or acute respiratory symptoms
* Chest radiograph without significant acute findings; or chest radiograph, CT, or MRI obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed
* History of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year =
1 pack-year) and non-smokers of at least 60 days duration prior to Screening
* Estimated creatinine clearance ≥ 80 mL/min at Screening
* Negative drug tests; including alcohol
* Hepatitis B, C, \& HIV Negative
* Surgically sterile or ≥ 12 months post-menopausal
* Non-pregnant females
Exclusion Criteria:
* Experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to Screening
* Plasma potassium ≥ 5 mEq/L
* Changes in chronic azithromycin use, bronchodilator (BD), dornase alfa, HS, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to Screening
* History of sputum or throat swab culture yielding Burkholderia species within 2 years of Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01840735
Study Brief:
Protocol Section:
NCT01840735