Trial Outcomes & Findings for Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis (NCT NCT00753987)

NCT ID: NCT00753987

Last Updated: 2025-02-13

Results Overview

Number of participants with a decrease in FEV0.5 by 0% or more after inhalation of hypertonic saline. The number of participants with a change in FEV0.5 of \*more than\* 0% is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 100 minutes
• Results posted on: 2025-02-13

Participant Flow

Participant milestones

Measure	Single Arm Interventional Trial Hypertonic Saline: 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

Baseline characteristics by cohort

Measure	Single Arm Study n=13 Participants Hypertonic Saline: 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.
Age, Customized Age, continuous	80.7 weeks STANDARD_DEVIATION 31.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Canada	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 minutes

Population: 2 infants had to excluded, since they woke up before administration of the study medication and thus lung function measurements after administration could not be performed

Number of participants with a decrease in FEV0.5 by 0% or more after inhalation of hypertonic saline. The number of participants with a change in FEV0.5 of *more than* 0% is reported.

Outcome measures

Measure	Decrease in FEV05 n=11 Participants There was no decrease in lung function observed in the study in any subject
Decrease in FEV0.5 After Inhalation of Hypertonic Saline	0 participants

SECONDARY outcome

Timeframe: 10 minutes

Reduction of oxygen saturation below 92 % 10 minutes after inhalation of hypertonic saline. This change would be considered to reflect an abnormally low oxygen concentration and could reflect a negative impact of inhalation

Outcome measures

Measure	Decrease in FEV05 n=11 Participants There was no decrease in lung function observed in the study in any subject
Oxygen Saturation Below 92%	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes after completion of inhalation

Population: CF infants

Diagnostic yield of a throat swab for microbiological diagnosis of bacteria as measured by the number of participants with newly detected bacterial pathogens on respiratory culture after inhalation of hypertonic saline compared to previously performed throat swabs at the last clinic visit

Outcome measures

Measure	Decrease in FEV05 n=13 Participants There was no decrease in lung function observed in the study in any subject
Number of Participants With Newly Detected Bacterial Pathogens on Throat Swab After Hypertonic Saline Inhalation	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 minutes

Population: Individuals with lung function data after inhalation

audible wheezing on auscultation 15 minutes after administration

Outcome measures

Measure	Decrease in FEV05 n=11 Participants There was no decrease in lung function observed in the study in any subject
Number of Participants With Wheezing After Inhalation of Hypertonic Saline	0 percentage of participants

Adverse Events

SIngle Arm Trial

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Felix Ratjen

SickKids

Phone: 4168137500

Email: felix.ratjen@sickkids.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place