Clinical trial
Efficacy of Nebulised 5% Hypertonic Saline in Children With Chronic Suppurative Lung Disease
Name
2020729-8926
Description
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
Trial arms
Trial start
2021-02-04
Estimated PCD
2023-08-28
Trial end
2023-08-28
Status
Completed
Phase
Early phase I
Treatment
Nebulized 5% Hypertonic saline
nebulized 0.9% saline
Arms:
5% Hypertonic saline, Placebo
Other names:
Placebo
Size
46
Primary endpoint
Change in the Short Parent-proxy cough quality of life (PC-QOL) score
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
at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind Placebo-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2023-12-01
1 organization
1 product
1 indication
Organization
University of MalayaIndication
Bronchiectasis