Trial · NCT00279916
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
NCT00279916, Phase 3, Completed, Mayo Clinic; results first posted 2011-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays. Trials, record NCT00279916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00279916
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
- NCT number
- NCT00279916
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Otitis Media, Serous, Negative Middle Ear Pressure, Rhinitis, Otitis Media With Effusion, Otitis Media, Secretory
- Interventions
- Triamcinolone acetonide nasal spray, Placebo nasal spray
- First posted
- 2006-01-20
- Last updated
- 2017-05-30
- Results first posted
- 2011-08-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Per-Ear Treatment Outcome | baseline, 6 weeks | 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. | ears | NUMBER |
| SECONDARY | Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | baseline, 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears | baseline, 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears | baseline, 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears | baseline, 6 weeks | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual | baseline, 6 weeks | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | Triamcinolone Acetonide | 7 | participants | ||
| Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | Placebo | 12 | participants | ||
| Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | Triamcinolone Acetonide | 5 | participants | ||
| Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | Placebo | 9 | participants | ||
| Per-Ear Treatment Outcome | Triamcinolone Acetonide | Initial Tympanogram of Type B or C | 55 | ears | |
| Per-Ear Treatment Outcome | Placebo | Initial Tympanogram of Type B or C | 57 | ears | |
| Per-Ear Treatment Outcome | Triamcinolone Acetonide | 6 weeks Complete Normalization (Type A) | 12 | ears | |
| Per-Ear Treatment Outcome | Placebo | 6 weeks Complete Normalization (Type A) | 20 | ears | |
| Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Triamcinolone Acetonide | Frequency - Better | 11 | participants | |
| Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears | Placebo | Frequency - Better | 18 | participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triamcinolone Acetonide | 45 | |
| Overall Study | STARTED | Placebo | 46 | |
| Overall Study | COMPLETED | Triamcinolone Acetonide | 38 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Triamcinolone Acetonide | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triamcinolone Acetonide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Triamcinolone Acetonide | 0 | 45 |
| Total, other adverse events | Placebo | 0 | 41 |
| Total, serious adverse events | Triamcinolone Acetonide | 0 | 45 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Triamcinolone Acetonide vs Placebo: Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution | Trial comparisons |
| Triamcinolone Acetonide vs Placebo: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment | Trial comparisons |
| Triamcinolone Acetonide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00279916
GET https://conductscience.org/api/trials/v1/NCT00279916/results?page=2