Clinical trial NCT04765033: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: CSLD
Child
Nebuliser
Hypertonic Saline
Outcome
Chronic cough
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind Placebo-controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Airway microbiome
timeFrame: At day 1 of randomization, at 3 months of use of study drug
measure: Number of Exacerbations
timeFrame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
measure: Number of Unscheduled Health Care Visits
timeFrame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
measure: No of episodes of rescue antibiotics
timeFrame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
measure: FEV1
timeFrame: At day 1 of randomization, at 3 months of use of study drug
measure: FVC
timeFrame: At day 1 of randomization, at 3 months of use of study drug
measure: FEF 25-75%
timeFrame: At day 1 of randomization, at 3 months of use of study drug
measure: PEFR ( pre and post), if possible
timeFrame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
measure: Cough diary
timeFrame: at -1 month of randomization, at day 1 of randomization, at 3 months of use of study drug
measure: Number of Adverse events
timeFrame: At day 1 of randomization, at 3 months of use of study drug
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Lembah Pantai
Study officials:
affiliation: UMMC
name: Anna M Nathan
role: PRINCIPAL_INVESTIGATOR
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