Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in Neuromuscular Disease or Neurodisability
Launched by IMPERIAL COLLEGE LONDON · Nov 10, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a special treatment called nebulised hypertonic saline (which is salty water) can help reduce the number of chest infections in people with neuromuscular diseases or cerebral palsy. These individuals often have trouble clearing mucus from their lungs, which can lead to frequent infections that require antibiotics. Over a 12-month period, participants will either receive the hypertonic saline or a regular saline solution using a nebulizer, which is a device that turns liquid medicine into a mist that can be inhaled.
To participate, individuals must be at least 5 years old, diagnosed with a neuromuscular condition, and have experienced at least one respiratory infection that required antibiotics in the past year. Before starting the treatment, participants will undergo several assessments to evaluate their lung health and quality of life. They will take the assigned treatment at home twice a day and have monthly check-ins with the research team. By the end of the study, the researchers hope to learn more about how effective nebulised hypertonic saline is for these patients, which could help doctors and families make better treatment choices in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of NMD or neurodisablity by a physician independent of the study, on standard criteria.
- • Age 5 years and above, including adults.
- • Must be able to tolerate nebulised 6% hypertonic saline.
- • Must have a history of at least one respiratory exacerbation requiring antibiotic treatment with or without the need for hospitalisation in the 12 months prior to recruitment.
- Exclusion Criteria:
- • Patients with additional diagnosis, for example, CF, but those with aspiration and/or bronchiectasis secondary to respiratory complications of NMD will be included.
- • Patients who are already prescribed daily HS in any concentration (i.e, 3%, 5%, 6%, 7%) will be excluded, but those who are on daily NS or have HS prescribed as part of their escalation plan (i.e., PRN) will be included.
About Imperial College London
Imperial College London is a world-renowned research institution based in the United Kingdom, recognized for its commitment to advancing medical science and improving patient care through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, Imperial combines expertise across various fields, including medicine, engineering, and business, to drive breakthroughs in healthcare. The institution’s robust clinical trial programs are designed to evaluate new therapies and interventions, ensuring rigorous scientific standards and ethical practices while aiming to translate research findings into tangible benefits for patients and society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Nottingham, , United Kingdom
Patients applied
Trial Officials
Andrew Bush, Professor
Principal Investigator
Imperial College London
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported