Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy (Nasonex OSA)

Children's & Women's Health Centre of British Columbia

Status and phase: Withdrawn; Phase 3

Conditions: Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography

Treatments: Drug: Placebo; Drug: Mometasone furoate nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01671852

H12-01653

Details and patient eligibility

About

Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe) as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed apneas and obstructive hypopneas).

Exclusion criteria

• Children with malformation syndromes or craniofacial anomalies
• Children with neuromuscular disorders
• Children with morbid obesity (body mass index ≥ 40)
• Children with asthma requiring steroid treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Nasonex

Active Comparator group

Description:

The intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.

Treatment:

Drug: Mometasone furoate nasal spray

Saline

Placebo Comparator group

Description:

The placebo group will receive saline nasal sprays for 8 weeks.

Treatment:

Drug: Placebo