Otitis Media, SerousPhase 3NCT00279916
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
A Phase 3 study testing Triamcinolone acetonide nasal spray in people with Otitis Media, Serous and Negative Middle Ear Pressure, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 100 years
- Conditions the study is for
- Otitis Media, Serous, Negative Middle Ear Pressure, Rhinitis
- What is being tested?
- Triamcinolone acetonide nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2005to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling to discontinue breast feeding, when applicable
- Active upper respiratory infection
- Nasopharyngeal mass
- Chronic infectious otitis media
- Cholesteatoma
- Acute infectious otitis media
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study
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).
Read the 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
- Being tested
- Triamcinolone acetonide nasal spray, Placebo nasal spray
- Medical subject headings
- Otitis Media with Effusion, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide nasal sprayDrug
Also called Nasacort AQ
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 nasal sprayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetonide | Active comparator | 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. Receives: Drug: Triamcinolone acetonide nasal spray |
| Placebo | Sham comparator | 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. Receives: Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (7)
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.
Measured: 6 weeks
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.
Measured: baseline, 6 weeks
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.
Measured: baseline, 6 weeks
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.
Measured: baseline, 6 weeks
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.
Measured: baseline, 6 weeks
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.
Measured: baseline, 6 weeks
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.
Measured: baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study start1 Sep 2005
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis Media, SerousStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Principal investigator, Laura Orvidas, Mayo Clinic
- Investigators
- Laura J. Orvidas, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279916
- Sponsor's protocol ID
- 103-04
- Other IDs
- IST4008
- Status last verified
- Apr 2017
- First submitted
- 18 Jan 2006
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21576556Mulvaney 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.
PubMed 38088821
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00279916
- Acronym / sponsor ID
- 103-04
- Conditions
- Otitis Media, Serous, Negative Middle Ear Pressure, Rhinitis, Otitis Media With Effusion, Otitis Media, Secretory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- 1 Sep 2005 (actual)
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Jan 2006 (estimated)
- Results
- Posted 15 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone acetonide nasal sprayTriamcinolone 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. |
| Placebo | Sham comparator | Drug: Placebo nasal sprayPlacebo 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. |
Who may qualify
- Ages
- 6 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Unwilling to discontinue breast feeding, when applicable
- Active upper respiratory infection
- Nasopharyngeal mass
- Chronic infectious otitis media
- Cholesteatoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetonide nasal sprayAlso: Nasacort AQSubjects 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). | Drug | Triamcinolone acetonide |
| Placebo nasal spraySubjects 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. | Drug | Placebo |
Primary outcome
Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
Time frame: 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.
7 secondary outcomes
Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
Time frame: 6 weeks
Per-Ear Treatment Outcome
Time frame: baseline, 6 weeks
Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
Time frame: baseline, 6 weeks
Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
Time frame: baseline, 6 weeks
Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
Time frame: baseline, 6 weeks
Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
Time frame: baseline, 6 weeks
Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
Time frame: baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21576556Gluth 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.
- Derived from this study: PubMed 38088821Mulvaney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J. Orvidas, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone acetonide nasal spray in people with Otitis Media, Serous and Negative Middle Ear Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279916, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.