NCT04765033

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

Completed Phase 4 Last updated 1 December 2023

What this trial tests

Phase 4 trial testing Nebulized 5% Hypertonic saline in Bronchiectasis in 46 participants. Completed in 28 August 2023.

Timeline

4 February 2021

Primary endpoint
28 August 2023

28 August 2023

Quick facts

Lead sponsor	University of Malaya
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	46
Start date	4 February 2021
Primary completion	28 August 2023
Estimated completion	28 August 2023
Sites	1 location across Malaysia

Drugs / interventions tested

• Nebulized 5% Hypertonic saline — full drug profile →

Conditions studied

• Bronchiectasis — all drugs for Bronchiectasis →

Sponsor

University of Malaya

Who can join

Adults 3 Months to 18, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mucolytics for children with chronic suppurative lung disease.
   O'Farrell HE, McElrea ER, Chang AB, Yerkovich ST, et al · · 2025 · cited 1× · PMID 40152354 · DOI 10.1002/14651858.cd015313.pub2