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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann M. Romaker, MD, Romaker & Associates
ClinicalTrials.gov Identifier:
NCT01089647
First received: March 17, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
Drug: budesonide nasal spray and a montelukast pill
Drug: Placebo: sugar pill and salt water nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults

Resource links provided by NLM:


Further study details as provided by Romaker & Associates:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: budesonide nasal spray and a montelukast pill
treatment arm
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
Placebo Comparator: sugar pill, salt water nasal spray
placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089647

Locations
United States, Missouri
Romaker & Associates
Kansas City, Missouri, United States, 64111
Romaker & Assoc
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Romaker & Associates
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ann Romaker, MD Romaker & Associates
  More Information

No publications provided

Responsible Party: Ann M. Romaker, MD, UMKC sleep fellowship program director, Romaker & Associates
ClinicalTrials.gov Identifier: NCT01089647     History of Changes
Other Study ID Numbers: Adult OSA drug study, IISP 37206
Study First Received: March 17, 2010
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Romaker & Associates:
OSA
Medical treatment

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Contraceptives, Oral
Budesonide
Montelukast
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists

ClinicalTrials.gov processed this record on August 28, 2014