Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Hypertonic Saline

Registration Number: NCT00753987

Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description: Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation.

Hypertonic saline (HS) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is also used in older children with CF, who do not produce sputum spontaneously, to obtain representative samples for microbiology.

There is evidence from studies in patients with cystic fibrosis that HS can improve mucociliary clearance. The improvement was more impressive in areas that were well ventilated, making it likely that HS will work better in patients with relatively preserved pulmonary function. Newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF patients.

As the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with HS may be most efficacious when initiated early in the disease process. So far, no data on the tolerability of inhalation of HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF infants is a prerequisite for longer term studies of HS in this age group. In older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of HS saline. Similar data are not yet available for infants.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tolerability of 7% hypertonic saline	Hypertonic Saline	Administration of a single dose of 7% hypertonic saline

Primary Outcome Measures

Name	Time	Method
Decrease in FEV0.5 After Inhalation of Hypertonic Saline	100 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation Below 92%	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