NCT00279916

Brief Summary

We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis media wit effusion in adults treated with placebo will be relatively low (minority of patients).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 15, 2011

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

January 18, 2006

Results QC Date

July 20, 2011

Last Update Submit

April 19, 2017

Conditions

Otitis Media, SerousNegative Middle Ear PressureRhinitisOtitis Media With EffusionOtitis Media, Secretory

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment

    Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.

    6 weeks

Secondary Outcomes (7)

  • Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution

    6 weeks

  • Per-Ear Treatment Outcome

    baseline, 6 weeks

  • Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears

    baseline, 6 weeks

  • Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears

    baseline, 6 weeks

  • Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears

    baseline, 6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Triamcinolone acetonide

ACTIVE COMPARATOR

Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration. Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration.

Drug: Triamcinolone acetonide nasal spray

Placebo

SHAM COMPARATOR

Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration. Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration.

Drug: Placebo nasal spray

Interventions

Triamcinolone acetonide nasal sprayDRUG

Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms). Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms).

Also known as: Nasacort AQ
Triamcinolone acetonide
Placebo nasal sprayDRUG

Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily. Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily.

Placebo

Eligibility Criteria

Age6 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 0-18 years
  • Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment
  • Pregnant

You may not qualify if:

  • Unwilling to discontinue breast feeding, when applicable
  • Active upper respiratory infection
  • Nasopharyngeal mass
  • Chronic infectious otitis media
  • Cholesteatoma
  • Acute infectious otitis media
  • History of otologic surgery other than placement of a pressure equalizer tube in the affected ear
  • History of radiation therapy to the head and neck region
  • Neuromuscular disease
  • Cystic fibrosis
  • Immunodeficiency
  • Mucociliary disorders
  • Craniofacial disorders/syndromes
  • Cleft palate
  • Development delay and/or symptoms suggestive of perilymph fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Gluth MB, McDonald DR, Weaver AL, Bauch CD, Beatty CW, Orvidas LJ. Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2011 May;137(5):449-55. doi: 10.1001/archoto.2011.56.

    PMID: 21576556RESULT

  • Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.

    PMID: 38088821DERIVED

MeSH Terms

Conditions

Otitis Media with EffusionRhinitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Dr. Laura Orvidas
Organization
Mayo Clinic
orvidas.laura@mayo.edu
507-284-3410

Study Officials

  • Laura J. Orvidas, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

September 1, 2005

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

May 30, 2017

Results First Posted

August 15, 2011

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)