Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Triamcinolone acetonide nasal spray (Drug)
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.
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
时间窗: 6 weeks
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.
次要结局
- Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears(baseline, 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 - Plugged Sensation in Ears(baseline, 6 weeks)
- Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears(baseline, 6 weeks)
- Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual(baseline, 6 weeks)
- Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution(6 weeks)