Pilot trial of the tolerability of hypertonic saline when delivered by a high-output nebuliser twice or four times daily to people with Cystic Fibrosis.

Withdrawn

• Conditions: Cystic fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12606000053527
• Lead Sponsor: Sydney South West Area Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Cystic fibrosis, member of RPA Hospital CF Clinic, stable clinical condition (no non-routine antibiotics in the previous 2 weeks), FEV1 >40% pred.

Exclusion Criteria

Unable/unwilling to provide informed consent, major haemoptysis in the previous year, pregnant or lactating, investigational drugs in the previous 30 days. There is no age limit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerance of the prescribed regimen of inhalation[Assessed at the end of the 2-week inhalation period]

Secondary Outcome Measures

Name	Time	Method
ung function[Measured at baseline and at the end of the 2-week inhalation period.];Oxyhaemoglobin saturation[Measured at baseline and at the end of the 2-week inhalation period.];Symptom severity on a visual analogue scale[Measured at baseline and at the end of the 2-week inhalation period.];Quality of life scores[Measured at baseline and at the end of the 2-week inhalation period.];Cytokine concentration[Measured at baseline and at the end of the 2-week inhalation period.];Bacterial load.[Measured at baseline and at the end of the 2-week inhalation period.]