Phase 3 N=91 Randomized Quadruple-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00279916 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcome: Primary: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment — 7; 12 participants — p=0.18

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Triamcinolone acetonide nasal spray (Drug); Placebo nasal spray (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment	7; 12	0.18
SECONDARY Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution	5; 9	0.24
SECONDARY Per-Ear Treatment Outcome	55; 57; 12; 20	—
SECONDARY Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears	11; 18; 17; 17; 10; 5	—
SECONDARY Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears	11; 8; 17; 23; 10; 9	—
SECONDARY Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears	0; 1; 10; 14; 13; 21	—
SECONDARY Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears	0; 1; 11; 8; 14; 18	—
SECONDARY Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual	0; 1; 16; 16; 14; 15	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00279916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.