Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children

Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial

MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.

MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.

Inclusion Criteria:

Each participant must meet all of the following criteria to be enrolled in this trial:

• Is between the ages of 3 and 12 years inclusive at the time of randomisation
• Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

• Has a BMI over the 97th centile for age and gender
• Has a history of tonsillectomy and/or adenoidectomy
• Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
• Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
• Has a history of nasal surgery or trauma which has not fully healed
• Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
• Is assessed to have stertor (snoring) while awake at rest
• Has a known hypersensitivity to the study drug or its formulation
• Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
• Daily use of antihistamine or decongestant nasal sprays
• Is known to require systemic steroids prior to the completion of the study treatment phase
• Has had treatment with any other investigational drug within 6 months prior to randomisation
• Is unable to provide consent without the aid of an interpreter.
• In the opinion of the Investigator may be unable to follow the protocol