NCT00560586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

November 15, 2007

Last Update Submit

July 5, 2017

Conditions

Obstructive Sleep Apnea

Keywords

sleep fragmentationapneahypoxia

Outcome Measures

Primary Outcomes (1)

  • Change in the number of apnea/hypopnea episodes during a sleep study

    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)

    Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.

Secondary Outcomes (3)

  • Pediatric sleep questionnaire (PSQ) at baseline

    Start of study

  • Pediatric sleep questionnaire (PSQ) after treatment

    6 weeks after drug treatment started

  • Pediatric sleep questionnaire (PSQ) after placebo

    6 weeks after placebo treatment started.

Study Arms (2)

Budesonide

EXPERIMENTAL

Budesonide for 6 weeks followed by crossover to placebo

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

Placebo for 6 weeks followed by crossover to treatment.

Drug: placebo

Interventions

BudesonideDRUG

1 puff each nostril (32 micrograms) at bedtime

Budesonide
placeboDRUG

1 puff each nostril at bedtime

Placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosair Children's Hospital Sleep Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • Kheirandish-Gozal L, Gozal D. Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome. Pediatrics. 2008 Jul;122(1):e149-55. doi: 10.1542/peds.2007-3398.

    PMID: 18595959DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep DeprivationApneaHypoxia

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Leila Kheirandish, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 19, 2007

Study Start

April 1, 2004

Primary Completion

May 1, 2006

Study Completion

August 1, 2007

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(1)