Steroids for Pediatric Apnea Research in Kids

Several studies have suggested that NCS or leukotriene antagonists may be effective in the
treatment of childhood OSAS. However, these studies have been limited by factors such as
small size, lack of randomization and blinding, short-term follow-up, involvement of children
with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore,
investigators will plan a randomized controlled trial evaluating the efficacy and safety of
NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS
will be safe and efficacious in the treatment of mild to moderate childhood OSAS,
particularly in children with asthma/atopy, but will require ongoing maintenance therapy.

Inclusion Criteria

1. 5-10 years of age.

2. Mild to moderate OSAS, defined as an obstructive apnea index of 1-20/hr of total sleep
time or obstructive apnea hypopnea index of 2-30/hr of total sleep time.

3. Parent-related symptoms of habitual snoring (>3 nights per week)

4. No history of adenotonsillectomy.

5. Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

1. Severe OSAS or significant hypoxemia or hypercapnia on polysomnography, such that
definitive treatment should not be delayed (AHI > 30/hr, more than 2% total sleep time
with SpO2 <90%, end-tidal PCO2 > 60 mm Hg for > 5 minutes, pathologic arrhythmias).

2. History of recurrent throat infections (as defined by the American Academy of
Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines For Tonsillectomy
(7)) in the past few years as follows: > 7 episodes in the past year or > 5
episodes/year over the past 2 years or > 3 episodes/year over the past 3 years.

3. Abnormalities on baseline safety screening tests, i.e., DXA scan showing spine or
whole body bone mineral density < -2.0 standard deviations using race specific curves
with adjustment for height Z-score; morning cortisol < 3 µg/dl or morning ACTH < 10
pg/ml; or ophthalmologic exam demonstrating cataracts (except those with < 2 mm
anterior polar cataracts), aphakia or other ocular abnormalities such as glaucoma,
retinal coloboma, intraocular inflammation or microphthalmia.

4. Failure to thrive (weight/height < 5th percentile for age and gender), as this may be
secondary to OSAS.

5. Severe obesity (BMI z-score > 3) as OSAS is likely to persist in these subjects.

6. Previous adenoidectomy unless adenoidal tissue has been documented to have regrown.

7. Previous tonsillectomy.

8. CPAP therapy.

9. Any NCS use in the past 3 months or NCS use for > 2 weeks in the past year.

10. Current immunotherapy or daily antihistamine use.

11. Recent (past month) nasal septum ulcers, surgery or trauma.

12. Other major illness other than asthma, such as craniofacial anomalies, endocrine or
neuromuscular disease, or past history of cancer. This includes children with
conditions that may be worsened by OSAS, such as hypertension or diabetes.

13. Current use of ketoconazole or other potent CYP3A4 inhibitors.

14. Families planning to move out of the area within the year.

15. Subjects who do not speak either English or Spanish well enough to complete the
validated neurobehavioral instruments.

16. Parents/guardians or subjects who, in the opinion of the Investigator, may be
non-compliant with study schedules or procedures.