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

This study is currently recruiting participants.
Verified July 2011 by Romaker & Associates
Sponsor:
Collaborators:
Merck
AstraZeneca
Information provided by:
Romaker & Associates
ClinicalTrials.gov Identifier:
NCT01089647
First received: March 17, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

March 17, 2010
July 19, 2011
September 2010
March 2012   (final data collection date for primary outcome measure)
decrease the number of apnea/hypopnea to <5 per hour of sleep [ Time Frame: 3 months ] [ Designated as safety issue: No ]
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
Same as current
Complete list of historical versions of study NCT01089647 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Drug: budesonide nasal spray and a montelukast pill
    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 and salt water nasal spray
    sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
  • Active Comparator: budesonide nasal spray and a montelukast pill
    treatment arm
    Intervention: Drug: budesonide nasal spray and a montelukast pill
  • Placebo Comparator: sugar pill, salt water nasal spray
    placebo
    Intervention: Drug: Placebo: sugar pill and salt water nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ann M Romaker, MD 816-756-2466 aromaker@romakersleep.com
United States
 
NCT01089647
Adult OSA drug study, IISP 37206
Yes
Ann M Romaker, MD, Romaker&Assoc
Romaker & Associates
  • Merck
  • AstraZeneca
Principal Investigator: Ann Romaker, MD Romaker & Associates
Romaker & Associates
July 2011

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