Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2014-09-30
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nasal steroids
Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
Nasal Fluticasone
One spray per nostril, per day.
Placebo
Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
Placebo
One spray per nostril, per day.
Interventions
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Nasal Fluticasone
One spray per nostril, per day.
Placebo
One spray per nostril, per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
5 Years
12 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Carole L Marcus, MBBCh
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Chidambaram AG, Cielo CM, Chervoneva I, Spergel JM, Tapia IE. Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome. J Clin Sleep Med. 2025 Jun 1;21(6):1033-1040. doi: 10.5664/jcsm.11604.
Tapia IE, Shults J, Cielo CM, Kelly AB, Elden LM, Spergel JM, Bradford RM, Cornaglia MA, Sterni LM, Radcliffe J. A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome. Chest. 2022 Oct;162(4):899-919. doi: 10.1016/j.chest.2022.06.026. Epub 2022 Jun 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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14-010942
Identifier Type: -
Identifier Source: org_study_id