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Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT00560586
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Brief Summary:
-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Budesonide Drug: placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome
Actual Study Start Date : April 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Budesonide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Budesonide
Budesonide for 6 weeks followed by crossover to placebo
Drug: Budesonide
1 puff each nostril (32 micrograms) at bedtime
Placebo Comparator: Placebo
Placebo for 6 weeks followed by crossover to treatment.
Drug: placebo
1 puff each nostril at bedtime



Primary Outcome Measures :
  1. Change in the number of apnea/hypopnea episodes during a sleep study [ Time Frame: Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started. ]
    Subjects will complete a sleep study with polysomnography at beginning of treatment and 6 weeks after start of treatment. Analysis of the sleep study will provide the number of times the subject has apnea (temporary cessation of breathing) or hypopnea (slow or shallow breathing)


Secondary Outcome Measures :
  1. Pediatric sleep questionnaire (PSQ) at baseline [ Time Frame: Start of study ]
    The PSQ is a 67 item instrument which has been validated in a wider age range, 4 to 18 years. The answers to the questions on the PSQ are: yes/no/don't know, which makes it simpler to use. The PSQ covers a wide range of sleep problems in children and has a sleepiness subscale, and a sleep related breathing disorder subscale, (which is the only non-PSG tool found to be useful in identifying obstructive sleep apnea). The PSQ has been used in clinical research and is applicable to screening as well. The scoring of this questionnaire will allow the investigators to determine any change in the quality of the subject's sleep.

  2. Pediatric sleep questionnaire (PSQ) after treatment [ Time Frame: 6 weeks after drug treatment started ]
    The PSQ is a 67 item instrument which has been validated in a wider age range, 4 to 18 years. The answers to the questions on the PSQ are: yes/no/don't know, which makes it simpler to use. The PSQ covers a wide range of sleep problems in children and has a sleepiness subscale, and a sleep related breathing disorder subscale, (which is the only non-PSG tool found to be useful in identifying obstructive sleep apnea). The PSQ has been used in clinical research and is applicable to screening as well. The scoring of this questionnaire will allow the investigators to determine any change in the quality of the subject's sleep.

  3. Pediatric sleep questionnaire (PSQ) after placebo [ Time Frame: 6 weeks after placebo treatment started. ]
    The PSQ is a 67 item instrument which has been validated in a wider age range, 4 to 18 years. The answers to the questions on the PSQ are: yes/no/don't know, which makes it simpler to use. The PSQ covers a wide range of sleep problems in children and has a sleepiness subscale, and a sleep related breathing disorder subscale, (which is the only non-PSG tool found to be useful in identifying obstructive sleep apnea). The PSQ has been used in clinical research and is applicable to screening as well. The scoring of this questionnaire will allow the investigators to determine any change in the quality of the subject's sleep.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children >6 years of age and < 12 years of age, who snore and have an apnea hypopnea index (AHI) < or equal 7 or Respiratory arousal index > or equal 2

Exclusion Criteria:

  • Hypersensitivity to budesonide
  • Recent nasal trauma
  • Nasal surgery or nasal septum perforation
  • Current therapy with drugs interacting with budesonide (erythromycin clarythromycin, ketoconazole and cimetidine)
  • Immunodeficiency or immunosuppressant therapy
  • Craniofacial, neuromuscular, syndromic or defined genetic abnormalities
  • Acute upper respiratory tract infection
  • Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and
  • Children who already had adenotonsillectomy in the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560586


Locations
United States, Kentucky
Kosair Children's Hospital Sleep Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Leila Kheirandish, MD University of Louisville

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00560586     History of Changes
Other Study ID Numbers: 388.03
UofL Project ID 04-0280X02
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by University of Louisville:
sleep fragmentation
apnea
hypoxia

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Rhinitis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists