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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2023
  • participants needed
    60
  • sponsor
    University of Malaya
Updated on 24 May 2022
antibiotics
cough

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

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.

Details
Condition Bronchiectasis
Treatment Placebo, Nebulized 5% Hypertonic saline
Clinical Study IdentifierNCT04765033
SponsorUniversity of Malaya
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
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