Obstructive Sleep Apnea
Conditions
Keywords
OSA, Medical treatment
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.
Interventions
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
DRUGPlacebo
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Sponsors
Merck Sharp & Dohme LLC
Romaker & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep | 3 months | by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range |
Countries
United States
Participant flow
Recruitment details
Thirty-four consecutive patients were recruited from the sleep medicine clinic at St. Luke's Health System from 24 June 2010 to 20 March 2013
Participants by arm
| Arm | Count |
|---|---|
| Placebo sugar pill, salt water nasal spray
Placebo: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks | 17 |
| Budesonide and Montelukast treatment arm
budesonide and montelukast: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Budesonide and Montelukast | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 17 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 17 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Region of Enrollment United States | 17 participants | 34 participants | 17 participants |
| Sex: Female, Male Female | 4 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 2 / 13 | 2 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Budesonide and Montelukast | Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep | 5 Participants |
| Placebo | Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep | 3 Participants |
Comparison: Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.p-value: =0.946ANOVA