NCT04765033

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

Efficacy of Nebulised 5% Hypertonic Saline in Children With Chronic Suppurative Lung Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary Aim: To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD. Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) Secondary Aims: To determine the: 1. Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics. Here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. Furthermore, Nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% HS. 2. Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will be doing portable spirometry ( pre and post bronchodilator). Patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) 3. Adverse effects of nebulized 5% hypertonic saline in children HS has been associated with side-effects. The investigators will monitor this. We will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Nebulized 5% Hypertonic saline	nebulized 0.9% saline

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2021-02-21
• Last updated: 2023-12-01

Locations

1 site across 1 country: Malaysia