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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:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279916
First received: January 18, 2006
Last updated: July 20, 2011
Last verified: July 2011
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Otitis Media, Serous
Negative Middle Ear Pressure
Rhinitis
Interventions: Drug: triamcinolone acetonide
Drug: placebo nasal spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment from 11/15/2005 through 9/5/08

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
Group 1 (Nasacort AQ Nasal Spray) 2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
Group 2 (Placebo Nasal Spray) 2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone

Participant Flow:   Overall Study
    Group 1 (Nasacort AQ Nasal Spray)     Group 2 (Placebo Nasal Spray)  
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
Group 1 (Nasacort AQ Nasal Spray) 2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
Group 2 (Placebo Nasal Spray) 2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
Total Total of all reporting groups

Baseline Measures
    Group 1 (Nasacort AQ Nasal Spray)     Group 2 (Placebo Nasal Spray)     Total  
Number of Participants  
[units: participants]
  45     46     91  
Age  
[units: Participants]
     
<=18 years     16     18     34  
Between 18 and 65 years     18     12     30  
>=65 years     11     16     27  
Age  
[units: years]
Mean ± Standard Deviation
  41.4  ± 28.4     42.0  ± 30.8     41.7  ± 29.5  
Gender  
[units: participants]
     
Female     30     16     46  
Male     15     30     45  
Tympanogram type in worst ear  
[units: participants]
     
A     0     0     0  
B     17     16     33  
C     28     30     58  



  Outcome Measures
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1.  Primary:   Complete Normalization   [ Time Frame: 6 weeks ]

2.  Secondary:   Complete Normalization, Including Treatment Failures   [ Time Frame: 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Laura Orvidas
Organization: Mayo Clinic
phone: 507-284-3410
e-mail: orvidas.laura@mayo.edu


No publications provided by Mayo Clinic

Publications automatically indexed to this study:

Responsible Party: Laura J Orvidas, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00279916     History of Changes
Other Study ID Numbers: 103-04, XRG5029C/4008
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board