Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IISP 37206 | Other Grant/Funding Number | Merck |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| budesonide and montelukast | Active Comparator | treatment arm |
|
| placebo | Placebo Comparator | sugar pill, salt water nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide and montelukast | Drug | budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ann Romaker, MD | Romaker & Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Romaker & Associates | Kansas City | Missouri | 64111 | United States | ||
| Romaker & Assoc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31383235 | Derived | Smith DF, Sarber KM, Spiceland CP, Ishman SL, Augelli DM, Romaker AM. Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients. J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876. |
Not provided
Not provided
Not provided
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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Budesonide and Montelukast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 3 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nosebleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | epistaxis |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Romaker | University of Cincinnati | 513-475-7500 | romakean@ucmail.uc.edu |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks |
|
| Kansas City |
| Missouri |
| 64111 |
| United States |
| Adverse Event |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | 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 | 0 | 13 | 0 | 13 | 2 | 13 |
|
| lower leg swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|