Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD. (NCT04765033) | Clinical Trial Compass
CompletedPhase 4
Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.
Malaysia46 participantsStarted 2021-02-04
Plain-language 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
Who can participate
Age range
3 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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