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

University of Malaya46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bronchiectasis

Interventions

Nebulized 5% Hypertonic salineDRUG

nebulized 0.9% saline

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Malaya Medical Centre

Kuala Lumpur, Lembah Pantai, Malaysia

Outcomes

Primary Outcomes

Change in the Short Parent-proxy cough quality of life (PC-QOL) score

Short PCQOL: This is a validated cough quality-of-life(QoL) questionnaire for parents of children with chronic cough, with a translated Malay version. Minimal Important Difference(MID) of 0.9 has been found in the validation study. The answers are on a Likert scale from 1 (every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version

Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug

Change in the Chronic Cough-specific QoL(CC-QOL) score

Chronic cough-specific QOL: This is a validated cough QoL questionnaire to be answered by children 7 years till 18 years old with a MID of about 1.1. The answers are in a Likert scale from 1 ( every time) to 7( none). A lower score denotes a lower quality of life. The patients will answer either the English or the translated Malay version

Time frame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug

Secondary Outcomes

Airway microbiome

DNA will be extracted from swabs using the Qiagen DNA Isolation Kit in accordance with the manufacturer's instructions. Bacterial profiling utilised the 16S rRNA gene targeting variable regions V3 - V4 will be carried out using Nextseq 2500 platform. Resulting raw fastq data will be processed using Dada2 R package and exported into phyloseq Rprogram for downstream analysis. The Alpha diversity will be measured using the Shannon and Simpson diversity indices while the beta diversity will be accessed using principle coordinate analysis and Permutational multivariate analysis of variance(PERMANOVA). Differentially abundant taxa will be identified by comparing the fold-change different using DESeq2.

Time frame: At day 1 of randomization, at 3 months of use of study drug

Number of Exacerbations

Defined as having one major and 2 minor OR 2 major criteria irrespective of whether antibiotics are prescribed. Criteria for exacerbation: Major: (1) Wet cough over 72 hours, (2) Severe cough over 72 hours Minor: (1) Change in Sputum colour, (2) Chest pain, (3) SOB, (4) Haemoptysis, (5) + ve Chest signs At -1 month, we will look at the no of exacerbations in the past 1 year. Before the use of the study drug and after 3 months of use of the study drug, we will look at the no of exacerbations in the preceding 1 month and 3 months, respectively.

Data from ClinicalTrials.gov

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