Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy

NCT ID: NCT01671852

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nasonex

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.

Group Type: ACTIVE_COMPARATOR

Mometasone furoate nasal spray

Intervention Type: DRUG

Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.

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.

Saline

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Mometasone furoate nasal spray

Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Nasonex

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Neil Chadha

Dr. Neil K. Chadha MBChB(Hons),MPHe BSc(Hons),FRCS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BC Women's and Children's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-01653

Identifier Type: -

Identifier Source: org_study_id