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Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)

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ClinicalTrials.gov Identifier: NCT01089647
Recruitment Status : Completed
First Posted : March 18, 2010
Results First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann M. Romaker, MD, Romaker & Associates

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 18, 2010
Results First Submitted Date  ICMJE September 11, 2018
Results First Posted Date  ICMJE December 3, 2018
Last Update Posted Date December 3, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep [ Time Frame: 3 months ]
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
decrease the number of apnea/hypopnea to <5 per hour of sleep [ Time Frame: 3 months ]
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
Change History Complete list of historical versions of study NCT01089647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Official Title  ICMJE Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
Brief Summary In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.
Detailed Description 40 adults with mild OSA (< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Drug: budesonide and montelukast
    budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
  • Drug: Placebo
    sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Study Arms  ICMJE
  • Active Comparator: budesonide and montelukast
    treatment arm
    Intervention: Drug: budesonide and montelukast
  • Placebo Comparator: placebo
    sugar pill, salt water nasal spray
    Intervention: Drug: Placebo
Publications * Smith DF, Sarber KM, Spiceland CP, Ishman SL, Augelli DM, Romaker AM. Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients. J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2010)
40
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 - 100 years
  • RDI between 5 - 15
  • all races
  • both sexes

Exclusion Criteria:

  • craniofacial, syndromic, neurological abnormalities
  • current or previous use of Singular, Rhinocort within last 6 months
  • acute upper respiratory infections
  • recent nasal trauma, nasal surgery, nasal septum perforation
  • known immunodeficiency or under going immunosuppressant therapy
  • current therapy with drugs that interact with Montelukast or Budesonide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089647
Other Study ID Numbers  ICMJE Adult OSA drug study
IISP 37206 ( Other Grant/Funding Number: Merck )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ann M. Romaker, MD, Romaker & Associates
Study Sponsor  ICMJE Romaker & Associates
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Ann Romaker, MD Romaker & Associates
PRS Account Romaker & Associates
Verification Date November 2018

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