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This study used hypertonic and isotonic saline along with labeled tracers (Indium-DTPA, Technetium Sulfur Colloid) to assess clearance processes in the lungs and examine therapeutic response. It included people aged 12 and older with cystic fibrosis confirmed by sweat test or genotype, their parents of a child with CF, and healthy controls. It was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Cystic Fibrosis Subjects: Inclusion Criteria * Ages 12 or older * Diagnosis of cystic fibrosis as determined by sweat test or genotype * Clinically stable as determined by a physician co-investigator Cystic Fibrosis Subjects: Exclusion Criteria * Smokers or users of electronic cigarettes * FEV1%p \<30% of predicted * Nursing, pregnant or unwilling to test for pregnancy * Intolerant to hypertonic saline * Unable or unwilling to discontinue hypertonic saline, Pulmozyme, and long acting bronchodilators for 24 hrs before testing and short acting bronchodilators on testing days. CF parents: Inclusion Criteria * Ages 18 and older * Biological parent of a CF patient who is also enrolled in the study CF parents: Exclusion Criteria * Smokers or users of electronic cigarettes * FEV1%p \<30% of predicted * Nursing, pregnant or unwilling to test for pregnancy * Unwilling to discontinue long acting bronchodilators for 24 hrs before testing and short acting bronchodilators on testing days. * Unwilling to perform CFTR genotyping. Healthy controls: Inclusion Criteria * Ages 18 and older * No history of lung disease Healthy Controls: Exclusion Criteria * Smokers or users of electronic cigarettes * FEV1%p \<70% of predicted * Nursing, pregnant or unwilling to test for pregnancy * Carriers of known disease causing CFTR mutations * Unwilling to perform CFTR genotyping.