Phase 1 Completed N=13 Treatment

Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

Cystic fibrosis

Source: ClinicalTrials.gov NCT00753987 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcomePrimary: Decrease in FEV0.5 After Inhalation of Hypertonic Saline — 0 participants

Summary

The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

Outcome Measures

Outcome	Result	p-value
PRIMARY Decrease in FEV0.5 After Inhalation of Hypertonic Saline	—	—
SECONDARY Oxygen Saturation Below 92%	—	—

Eligibility Criteria

Inclusion Criteria

Confirmed diagnosis of cystic fibrosis
Age 2 months to 2 years
Routinely scheduled infant pulmonary function test.
Clinical stability (no respirator tract infection for 4 weeks prior to study

Exclusion Criteria

Acute respiratory symptoms
Wheezing at the time of study
Supplemental oxygen therapy
Oxygen saturation < 95 % on room air

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00753987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.