Steroids for Pediatric Apnea Research in Kids

NCT02180672 | Completed Phase 3 Results DMC

• 2 other identifiers: 14-010942R01HL120909
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive sleep apnea syndrome; OSA; sleep apnea; nasal steroids; corticosteroids

Outcome Measures

Primary Outcomes (1)

• Obstructive Apnea Hypopnea Index

  Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.

  3 months

Secondary Outcomes (9)

• OAHI

  12 months

• Nasal Obstruction Symptom Evaluation (NOSE)

  12 months

• The Epworth Sleepiness Scale

  12 months

• Pediatric Quality of Life Inventory (PedsQL)

  12 month

• Behavior Rating Inventory of Executive Function (BRIEF)

  12 months

Study Arms (2)

Nasal steroids

ACTIVE COMPARATOR

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

Drug: Nasal Fluticasone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nasal Fluticasone DRUG

One spray per nostril, per day.

Also known as: NCS, Nasal steroids, Nasal corticosteroids

Nasal steroids

Placebo DRUG

One spray per nostril, per day.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age.
• 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.
• Parent-related symptoms of habitual snoring (\>3 nights per week)
• No history of adenotonsillectomy.
• Parental/guardian permission (informed consent) and if appropriate, child assent

You may not qualify if:

• 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).
• 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.
• 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.
• Failure to thrive (weight/height \< 5th percentile for age and gender), as this may be secondary to OSAS.
• Severe obesity (BMI z-score \> 3) as OSAS is likely to persist in these subjects.
• Previous adenoidectomy unless adenoidal tissue has been documented to have regrown.
• Previous tonsillectomy.
• Continuous positive airway pressure (CPAP) therapy.
• Any NCS use in the past 3 months or NCS use for \> 2 weeks in the past year.
• Current immunotherapy or daily antihistamine use.
• Recent (past month) nasal septum ulcers, surgery or trauma.
• 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.
• Current use of ketoconazole or other potent CYP3A4 inhibitors.
• Families planning to move out of the area within the year.
• Subjects who do not speak either English or Spanish well enough to complete the validated neurobehavioral instruments.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 40051199 DERIVED

• 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.

  PMID: 35779610 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Ignacio Tapia, MD, Principal Investigator, Associate Professor
• Organization: The Children's Hospital of Philadelphia

tapia@chop.edu

(267) 426-5842

Study Officials

• Carole L Marcus, MBBCh

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 3, 2014
• Study Start: September 1, 2014
• Primary Completion: December 30, 2019
• Study Completion: October 30, 2021
• Last Updated: November 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-11

Locations

US (1)