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

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Brief Title

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

Official Title

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

Brief 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Airway microbiome

Condition

Bronchiectasis

Intervention

Nebulized 5% Hypertonic saline

Study Arms / Comparison Groups

 5% Hypertonic saline
Description:  5% hypertonic saline nebuliser 4 mls twice in a day for 3 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

February 4, 2021

Completion Date

February 28, 2023

Primary Completion Date

February 28, 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

3 Months - 18 Years

Accepts Healthy Volunteers

No

Contacts

Anna M Nathan, 603-79493643/ 0122123503, [email protected]

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations


NCT ID

NCT04765033

Organization ID

2020729-8926


Responsible Party

Principal Investigator

Study Sponsor

University of Malaya


Study Sponsor

Anna M Nathan, Principal Investigator, UMMC


Verification Date

February 2021