NCT00753987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
16.4 years until next milestone

Results Posted

Study results publicly available

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

September 15, 2008

Results QC Date

October 3, 2018

Last Update Submit

January 27, 2025

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisHypertonic SalineInfants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Oxygen Saturation Below 92%

    10 minutes

Other Outcomes (2)

  • Number of Participants With Newly Detected Bacterial Pathogens on Throat Swab After Hypertonic Saline Inhalation

    10 minutes after completion of inhalation

  • Number of Participants With Wheezing After Inhalation of Hypertonic Saline

    15 minutes

Study Arms (1)

Tolerability of 7% hypertonic saline

EXPERIMENTAL

Administration of a single dose of 7% hypertonic saline

Drug: Hypertonic Saline

Interventions

Hypertonic SalineDRUG

5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.

Tolerability of 7% hypertonic saline

Eligibility Criteria

Age2 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Felix Ratjen
Organization
SickKids
felix.ratjen@sickkids.ca
4168137500

Study Officials

  • Felix Ratjen, MD, FRCP(C)

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Respiratory Medicine

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

March 1, 2006

Primary Completion

July 1, 2006

Study Completion

January 1, 2007

Last Updated

February 13, 2025

Results First Posted

February 13, 2025

Record last verified: 2025-01

Locations

CA(1)