Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays

NCT ID: NCT00279916

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-01
• Study Completion Date: 2009-03-31

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).

Detailed Description

Newer intranasal steroid preparations are generally safe with relatively few side effects as demonstrated in large studies dealing with allergic rhinitis.

Eustachian Tube Dysfunction (ETD) primarily refers to an absent or inadequate ability to open the eustachian tube. The term Serous Otitis Media (SOM) generally referring to an accumulation of fluid within the middle ear space, in absence of signs indicating acute infection. Commonly, this can result in a conductive hearing loss due to restriction of tympanic membrane mobility. Negative Middle Ear Pressure (NMEP) is often a precursor to the development of SOM, and has it's own effect on the acoustic properties of the middle ear, also resulting in conductive hearing loss.

Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition, it is common practice for some physicians to take a "wait and see" initial approach when this clinical entity is encountered in lieu of prescribing unproved medications. It is generally accepted that some patients with Negative Middle Ear Pressure (NMEP) and/or Serous Otitis Media (SOM) will undergo spontaneous resolution of symptoms, yet the exact resolution rates are not clearly defined.

The purpose of this double-blind, randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure. Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study.

Resolution of ETD symptoms will be measured by changes in the tympanogram, a test to measure pressure within the middle ear. This measurement will be taken at baseline and after 6 weeks of treatment.

Conditions

Otitis Media, Serous; Negative Middle Ear Pressure; Rhinitis; Otitis Media With Effusion; Otitis Media, Secretory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Triamcinolone acetonide

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.

Group Type: ACTIVE_COMPARATOR

Triamcinolone acetonide nasal spray

Intervention Type: DRUG

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).

Placebo

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.

Group Type: SHAM_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

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.

Interventions

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).

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

Intervention Type: DRUG

Placebo nasal spray

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.

Intervention Type: DRUG

Other Intervention Names

Nasacort AQ

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Laura Orvidas

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura J. Orvidas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21576556 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38088821 (View on PubMed)

Other Identifiers

IST4008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

103-04

Identifier Type: -

Identifier Source: org_study_id