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

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ClinicalTrials.gov Identifier: NCT00279916
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : August 15, 2011
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Laura Orvidas, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Otitis Media, Serous
Negative Middle Ear Pressure
Rhinitis
Otitis Media With Effusion
Otitis Media, Secretory
Interventions Drug: Triamcinolone acetonide nasal spray
Drug: Placebo nasal spray
Enrollment 91
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.
Pre-assignment Details  
Arm/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 45 46
Completed 38 41
Not Completed 7 5
Reason Not Completed
Withdrawal by Subject             4             3
Lost to Follow-up             3             2
Arm/Group Title Triamcinolone Acetonide Placebo Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 45 46 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 91 participants
<=18 years
16
  35.6%
18
  39.1%
34
  37.4%
Between 18 and 65 years
18
  40.0%
12
  26.1%
30
  33.0%
>=65 years
11
  24.4%
16
  34.8%
27
  29.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 46 participants 91 participants
41.4  (28.4) 42.0  (30.8) 41.7  (29.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 91 participants
Female
30
  66.7%
16
  34.8%
46
  50.5%
Male
15
  33.3%
30
  65.2%
45
  49.5%
Tympanogram type in worst ear  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 91 participants
A; peak pressure under -100 kPa 0 0 0
B; non-peaked or flat pressure 17 16 33
C; peaked pressure greater than -100 kPa 28 30 58
1.Primary Outcome
Title Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 37 37
Measure Type: Number
Unit of Measure: participants
7 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 37 37
Measure Type: Number
Unit of Measure: participants
5 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Per-Ear Treatment Outcome
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 37 37
Measure Type: Number
Unit of Measure: ears
Initial Tympanogram of Type B or C 55 57
6 weeks Complete Normalization (Type A) 12 20
4.Secondary Outcome
Title Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
Frequency - Better 11 18
Frequency - Same 17 17
Frequency - Worse 10 5
Severity - Better 13 18
Severity - Same 14 13
Severity - Worse 11 9
5.Secondary Outcome
Title Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
Frequency - Better 11 8
Frequency - Same 17 23
Frequency - Worse 10 9
Severity - Better 9 6
Severity - Same 19 25
Severity - Worse 10 9
6.Secondary Outcome
Title Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
Frequency - Missing 0 1
Frequency - Better 10 14
Frequency - Same 13 21
Frequency - Worse 15 4
Severity - Missing 0 1
Severity - Better 15 14
Severity - Same 8 16
Severity - Worse 15 9
7.Secondary Outcome
Title Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
Frequency - Missing 0 1
Frequency - Better 11 8
Frequency - Same 14 18
Frequency - Worse 13 13
Severity - Missing 0 2
Severity - Better 9 6
Severity - Same 17 19
Severity - Worse 12 13
8.Secondary Outcome
Title Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
Frequency - Missing 0 1
Frequency - Better 16 16
Frequency - Same 14 15
Frequency - Worse 8 8
Severity - Missing 0 1
Severity - Better 15 14
Severity - Same 13 15
Severity - Worse 10 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triamcinolone Acetonide Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Triamcinolone Acetonide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone Acetonide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Triamcinolone Acetonide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/41 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Laura Orvidas
Organization: Mayo Clinic
Phone: 507-284-3410
Responsible Party: Laura Orvidas, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00279916     History of Changes
Other Study ID Numbers: 103-04
IST4008 ( Other Grant/Funding Number: Sanofi-Aventis US, LLC )
First Submitted: January 18, 2006
First Posted: January 20, 2006
Results First Submitted: July 20, 2011
Results First Posted: August 15, 2011
Last Update Posted: May 30, 2017