Steroids for Pediatric Apnea Research in Kids (SPARK)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 3

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Drug: Nasal Fluticasone; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02180672

14-010942

R01HL120909 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.

Full description

Several studies have suggested that Nasal corticosteroids (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.

Enrollment: 211 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 arterial oxygen saturation (SpO2) <90%, end-tidal carbon dioxide partial pressure (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., Dual Energy X-ray Absorptiometry (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 adrenocorticotropic hormone (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. Continuous positive airway pressure (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

211 participants in 2 patient groups, including a placebo group

Nasal steroids

Active Comparator group

Description:

Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).

Treatment:

Drug: Nasal Fluticasone

Placebo

Placebo Comparator group

Description:

Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).

Treatment:

Drug: Placebo