Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: Hypertonic Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tolerability of 7% hypertonic saline; Administration of a single dose of 7% hypertonic saline	Drug: Hypertonic Saline; 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in FEV0.5 After Inhalation of Hypertonic Saline	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.	100 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Below 92%	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	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Newly Detected Bacterial Pathogens on Throat Swab After Hypertonic Saline Inhalation	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	10 minutes after completion of inhalation
Number of Participants With Wheezing After Inhalation of Hypertonic Saline	audible wheezing on auscultation 15 minutes after administration	15 minutes

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Felix Ratjen, MD, FRCP(C), The Hospital for Sick Children

Publications and helpful links

Helpful Links

• Link to published study results

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: September 15, 2008
• First Submitted That Met QC Criteria: September 15, 2008
• First Posted (Estimated): September 17, 2008

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Hypertonic Saline; Infants
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 1000008380