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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00889434
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of CF.
2. Abnormal chloride secretion as measured by TEPD (a less than -5 mV TEPD assessment of chloride secretion with chloride-free amiloride and isoproterenol).
3. Presence of a splicing mutation in at least one allele of the CFTR gene.
4. Willingness and ability to comply with scheduled visits, drug administration plan, study procedures (including TEPD measurements, clinical laboratory tests,), and study restrictions.
5. Ability to provide written informed consent.
6. Evidence of personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
Exclusion Criteria:
1. Prior or ongoing medical condition (e.g., concomitant illness, alcoholism, drug abuse, psychiatric condition), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the patient, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
2. Ongoing acute illness including acute upper or lower respiratory infections within 2 weeks before start of study treatment.
3. History of major complications of lung disease (including recent massive hemoptysis or pneumothorax) within 2 months prior to start of study treatment.
4. Abnormalities on screening chest x-ray suggesting clinically significant active pulmonary disease other than CF, or new, significant abnormalities such as atelectasis or pleural effusion which may be indicative of clinically significant active pulmonary involvement secondary to CF.
5. Abnormal liver function (serum ALT, AST, GGT, alkaline phosphatase, LDH, or total bilirubin \> 2 times upper limit of normal). Abnormal renal function (serum creatinine \>1.5 times upper limit of normal).
6. Pregnancy or breast-feeding.
7. History of solid organ or hematological transplantation.
8. Ongoing participation in any other therapeutic clinical trial or exposure to another investigational drug within 14 days prior to start of study treatment.
9. Change in intranasal medications (including use of corticosteroids, cromolyn, ipratropium bromide, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment.
10. Change in treatment with systemic or inhaled corticosteroids within 14 days prior to start of study treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00889434
Study Brief:
Protocol Section:
NCT00889434