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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Laura Orvidas, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279916
First received: January 18, 2006
Last updated: April 19, 2017
Last verified: April 2017
Results First Received: July 20, 2011  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Triamcinolone Acetonide   Placebo
STARTED   45   46 
COMPLETED   38   41 
NOT COMPLETED   7   5 
Withdrawal by Subject                4                3 
Lost to Follow-up                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   Triamcinolone Acetonide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   46   91 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 41.4  (28.4)   42.0  (30.8)   41.7  (29.5) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: 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 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment   [ Time Frame: 6 weeks ]

2.  Secondary:   Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution   [ Time Frame: 6 weeks ]

3.  Secondary:   Per-Ear Treatment Outcome   [ Time Frame: baseline, 6 weeks ]

4.  Secondary:   Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears   [ Time Frame: baseline, 6 weeks ]

5.  Secondary:   Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears   [ Time Frame: baseline, 6 weeks ]

6.  Secondary:   Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears   [ Time Frame: baseline, 6 weeks ]

7.  Secondary:   Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears   [ Time Frame: baseline, 6 weeks ]

8.  Secondary:   Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual   [ Time Frame: baseline, 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: orvidas.laura@mayo.edu


Publications of Results:

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 )
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: April 19, 2017