Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00753987
First received: September 15, 2008
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Hypertonic Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Infant tolerance of inhalation of hypertonic saline [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]
  • The immediate effect of HS on lung function in infants with CF, as measured by differences in expiratory flows before and after inhalation of hypertonic saline [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The usefulness of inhalation of hypertonic saline as a technique to obtain secretions from the lower respiratory tract for microbiological diagnosis [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2006
Study Completion Date: January 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Hypertonic Saline
5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.

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.

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753987

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Felix Ratjen, MD, FRCP(C) The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00753987     History of Changes
Other Study ID Numbers: 1000008380
Study First Received: September 15, 2008
Last Updated: August 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Cystic Fibrosis
Hypertonic Saline
Infants

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014