Obstructive Sleep ApneaPhase 3NCT01089647
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
A Phase 3 study testing budesonide and montelukast in people with Obstructive Sleep Apnea, run by Romaker & Associates at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- budesonide and montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 100 years
- RDI between 5 - 15
- all races
- both sexes
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Romaker & Associates
Kansas City, Missouri, 64111
Romaker & Assoc
Kansas City, Missouri, 64111
About this study
Official title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- budesonide and montelukast, Placebo
- Keywords
- OSA, Medical treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide and montelukastDrug
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
PlaceboDrug
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| budesonide and montelukast | Active comparator | treatment arm Receives: Drug: budesonide and montelukast |
| placebo | Placebo comparator | sugar pill, salt water nasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romaker & Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Ann M. Romaker, MD, Romaker & Associates
- Investigators
- Ann Romaker, MD, Principal investigator, Romaker & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089647
- Sponsor's protocol ID
- Adult OSA drug study
- Other IDs
- IISP 37206
- Status last verified
- Nov 2018
- First submitted
- 17 Mar 2010
- Last updated
- 3 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31383235
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
- ClinicalTrials.gov ID
- NCT01089647
- Acronym / sponsor ID
- Adult OSA drug study
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Medical treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Romaker & AssociatesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Posted 3 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| budesonide and montelukast | Active comparator | Drug: budesonide and montelukasttreatment arm |
| placebo | Placebo comparator | Drug: Placebosugar pill, salt water nasal spray |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 - 100 years
- RDI between 5 - 15
- all races
- both sexes
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide and montelukastbudesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks | Drug | budesonide and montelukast |
| Placebosugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks | Drug | placebo |
Primary outcome
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
Time frame: 3 months
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31383235Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Romaker, MD principal investigator
Romaker & Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide and montelukast in people with Obstructive Sleep Apnea, run by Romaker & Associates at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.