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:
Romaker & Associates
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
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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: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089647
Contacts
| Contact: Ann M Romaker, MD | 816-756-2466 | aromaker@romakersleep.com |
Locations
| United States, Missouri | |
| Romaker & Associates | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Ann Romaker, MD 816-756-2466 aromaker@romakersleep.com | |
| Principal Investigator: Ann Romaker, MD | |
| Romaker & Assoc | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Ann M Romaker, MD 816-756-2466 aromaker@romakersleep.com | |
| Principal Investigator: Ann M Romaker, MD | |
Sponsors and Collaborators
Romaker & Associates
Merck
AstraZeneca
Investigators
| Principal Investigator: | Ann Romaker, MD | Romaker & Associates |
More Information
No publications provided
| Responsible Party: | Ann M Romaker, MD, Romaker&Assoc |
| 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: | July 19, 2011 |
| 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 Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Leukotriene Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013