NCT01089647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

December 3, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

3.8 years

First QC Date

March 17, 2010

Results QC Date

September 11, 2018

Last Update Submit

November 30, 2018

Conditions

Obstructive Sleep Apnea

Keywords

OSAMedical treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

budesonide and montelukast

ACTIVE COMPARATOR

treatment arm

Drug: budesonide and montelukast

placebo

PLACEBO COMPARATOR

sugar pill, salt water nasal spray

Drug: Placebo

Interventions

budesonide and montelukastDRUG

budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks

budesonide and montelukast
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 - 100 years
  • RDI between 5 - 15
  • all races
  • both sexes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Romaker & Associates

Kansas City, Missouri, 64111, United States

Location

Romaker & Assoc

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • 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.

    PMID: 31383235DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Budesonidemontelukast

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Ann Romaker
Organization
University of Cincinnati
romakean@ucmail.uc.edu
513-475-7500

Study Officials

  • Ann Romaker, MD

    Romaker & Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UMKC sleep fellowship program director

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 18, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 3, 2018

Results First Posted

December 3, 2018

Record last verified: 2018-11

Locations

US(2)