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

NCT01671852 | Withdrawn Phase 3

• 1 other identifier: H12-01653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  This wil be measured by polysomnography.

  8 weeks

Secondary Outcomes (8)

• Respiratory Disturbance Index

  At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)

• Desaturation index

  At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)

• Respiratory arousal index

  At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)

• Nadir of arterial oxygen saturation

  At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)

• Mean arterial oxygen saturation

  At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)

Study Arms (2)

Nasonex

ACTIVE COMPARATOR

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.

Drug: Mometasone furoate nasal spray

Saline

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mometasone furoate nasal spray 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.

Also known as: Nasonex

Nasonex

Placebo DRUG

Saline

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (1)

BC Women's and Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Lymphoma, Follicular

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Neil K. Chadha MBChB(Hons),MPHe BSc(Hons),FRCS

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: August 24, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

CA (1)