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

Obstructive Sleep Apnea Clinical Trial

Official title:

Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089647
• Other study ID #: Adult OSA drug study
• Secondary ID: IISP 37206
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2018
• Source: Romaker & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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
• Placebo
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

Locations

Country	Name	City	State
United States	Romaker & Assoc	Kansas City	Missouri
United States	Romaker & Associates	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Romaker & Associates	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep	by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range	3 months