Negative Middle Ear Pressure, Otitis Media, Secretory, Otitis Media, Serous, Otitis Media With Effusion, Rhinitis
Conditions
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.
Interventions
DRUGTriamcinolone 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).
DRUGPlacebo 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.
Sponsors
Aventis Pharmaceuticals
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-Ear Treatment Outcome | baseline, 6 weeks | Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. 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. |
| Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | baseline, 6 weeks | As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. |
| Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | baseline, 6 weeks | As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. |
| Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | 6 weeks | For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination. |
| Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | baseline, 6 weeks | As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. |
| Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | baseline, 6 weeks | As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. |
| Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | baseline, 6 weeks | As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse. |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from the patients seen at the Mayo Clinic Department of Otorhinolaryngology (Ears, Nose and Throat) in Rochester, Minnesota. Enrollment occurred from 09/01/2005 through 12/31/2008.
Participants by arm
| Arm | Count |
|---|---|
| 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 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration. | 45 |
| 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 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration. | 46 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Placebo | Triamcinolone Acetonide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Categorical >=65 years | 16 Participants | 11 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 18 Participants | 30 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 30.8 | 41.4 years STANDARD_DEVIATION 28.4 | 41.7 years STANDARD_DEVIATION 29.5 |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 46 Participants |
| Sex: Female, Male Male | 30 Participants | 15 Participants | 45 Participants |
| Tympanogram type in worst ear A; peak pressure under -100 kPa | 0 participants | 0 participants | 0 participants |
| Tympanogram type in worst ear B; non-peaked or flat pressure | 16 participants | 17 participants | 33 participants |
| Tympanogram type in worst ear C; peaked pressure greater than -100 kPa | 30 participants | 28 participants | 58 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 41 |
| serious Total, serious adverse events | 0 / 45 | 0 / 41 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | 7 participants |
| Placebo | Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | 12 participants |
p-value: 0.18Chi-squared
Secondary
Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination.
Time frame: 6 weeks
Population: Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Triamcinolone Acetonide | Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | 5 participants |
| Placebo | Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | 9 participants |
p-value: 0.24Chi-squared
Secondary
Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Missing | 0 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Better | 16 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Same | 14 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Worse | 8 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Missing | 0 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Better | 15 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Same | 13 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Worse | 10 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Worse | 10 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Missing | 1 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Missing | 1 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Better | 16 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Same | 15 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Same | 15 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Severity - Better | 14 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | Frequency - Worse | 8 participants |
Secondary
Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Better | 11 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Same | 17 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Worse | 10 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Same | 14 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Worse | 11 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Better | 13 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Better | 18 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Better | 18 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Worse | 9 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Same | 17 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Severity - Same | 13 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Frequency - Worse | 5 participants |
Secondary
Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Better | 11 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Same | 17 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Worse | 10 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Better | 9 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Same | 19 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Worse | 10 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Same | 25 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Better | 8 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Better | 6 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Same | 23 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Severity - Worse | 9 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | Frequency - Worse | 9 participants |
Secondary
Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Missing | 0 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Better | 10 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Same | 13 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Worse | 15 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Missing | 0 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Better | 15 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Same | 8 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Worse | 15 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Worse | 9 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Missing | 1 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Missing | 1 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Better | 14 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Same | 16 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Same | 21 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Severity - Better | 14 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | Frequency - Worse | 4 participants |
Secondary
Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Better | 9 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Missing | 0 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Same | 14 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Better | 11 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Same | 17 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Worse | 13 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Worse | 12 participants |
| Triamcinolone Acetonide | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Missing | 0 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Worse | 13 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Missing | 1 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Better | 8 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Same | 18 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Frequency - Worse | 13 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Missing | 2 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Better | 6 participants |
| Placebo | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | Severity - Same | 19 participants |
Secondary
Per-Ear Treatment Outcome
Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. 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.
Time frame: baseline, 6 weeks
Population: Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Triamcinolone Acetonide | Per-Ear Treatment Outcome | Initial Tympanogram of Type B or C | 55 ears |
| Triamcinolone Acetonide | Per-Ear Treatment Outcome | 6 weeks Complete Normalization (Type A) | 12 ears |
| Placebo | Per-Ear Treatment Outcome | Initial Tympanogram of Type B or C | 57 ears |
| Placebo | Per-Ear Treatment Outcome | 6 weeks Complete Normalization (Type A) | 20 ears |