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Steroids for Pediatric Apnea Research in Kids (SPARK)

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ClinicalTrials.gov Identifier: NCT02180672
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE July 1, 2014
First Posted Date  ICMJE July 3, 2014
Last Update Posted Date July 8, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Apnea hypopnea index [ Time Frame: 3 months ]
Efficacy measure to assess acute response to nasal steroids.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02180672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • AHI [ Time Frame: 12 months ]
    Efficacy measure to assess duration of response to nasal steroids.
  • Nasal Obstruction Symptom Evaluation (NOSE) [ Time Frame: 12 months ]
  • The Epworth Sleepiness Scale [ Time Frame: 12 months ]
  • The Child Behavior Checklist (CBCL) [ Time Frame: 12 months ]
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 12 month ]
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 12 months ]
  • Conners Abbreviated Symptom Questionnaire [ Time Frame: 12 months ]
  • Conners Kiddie Continuous Performance Test, Version 5 (K-CPT) [ Time Frame: 12 months ]
  • Purdue Peg Board [ Time Frame: 12 months ]
  • Knee height [ Time Frame: 12 months ]
  • DXA-measured bone density [ Time Frame: 12 months ]
  • cortisol level [ Time Frame: 12 months ]
  • Ophthalmologic exam [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroids for Pediatric Apnea Research in Kids
Official Title  ICMJE Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea Syndrome
Intervention  ICMJE
  • Drug: Nasal Fluticasone
    One spray per nostril, per day.
    Other Names:
    • NCS
    • Nasal steroids
    • Nasal corticosteroids
  • Drug: Placebo
    One spray per nostril, per day.
    Other Name: Saline
Study Arms  ICMJE
  • Active Comparator: Nasal steroids
    Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
    Intervention: Drug: Nasal Fluticasone
  • Placebo Comparator: Placebo
    Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
318
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ruth Bradford 2674265747 bradford@email.chop.edu
Contact: Mary Anne Cornaglia 2674265748 cornaglia@email.chop.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02180672
Other Study ID Numbers  ICMJE 14-010942
R01HL120909 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Carole L Marcus, MBBCh Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP