CompletedPhase 4

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

Malaysia46 participantsStarted 2021-02-04

Plain-language 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

Who can participate

Age range3 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT04765033

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-28

View on ClinicalTrials.gov More Bronchiectasis trials