Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.

Secondary Aims:

To determine the:

1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.

2. Efficacy of nebulized 5% hypertonic saline on lung function

3. Adverse effects of nebulized 5% hypertonic saline in children

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya

Criteria

Inclusion Criteria:

• Patients < 18 years old

• Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD

Exclusion Criteria:

• Incomplete data or refusal to participate

• Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD

• On supplementary oxygen/home ventilation

• Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.

• Oral antibiotics for less than 4 weeks before randomization for medication.

• Fall in PEFR > 20% post 5% HS challenge test or a positive HS challenge test in young children, as mentioned below.