Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.
NCT ID: NCT04765033
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
46 participants
INTERVENTIONAL
2021-02-04
2023-08-28
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5% Hypertonic saline
5% hypertonic saline nebuliser 4 mls twice in a day for 3 months
Nebulized 5% Hypertonic saline
nebulized 0.9% saline
Placebo
0.9% saline nebuliser 4 mls twice in a day for 3 months
Nebulized 5% Hypertonic saline
nebulized 0.9% saline
Interventions
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Nebulized 5% Hypertonic saline
nebulized 0.9% saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD
Exclusion Criteria
* 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.
3 Months
18 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Anna Marie Nathan
Consultant and Professor
Principal Investigators
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Anna M Nathan
Role: PRINCIPAL_INVESTIGATOR
UMMC
Locations
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University Malaya Medical Centre
Kuala Lumpur, Lembah Pantai, Malaysia
Countries
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References
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Other Identifiers
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2020729-8926
Identifier Type: -
Identifier Source: org_study_id