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

This study has been completed.

Study NCT00279916 Information provided by Mayo Clinic

First Received on January 18, 2006. Last Updated on July 20, 2011 History of Changes

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

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
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

Hide Baseline Characteristics

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

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

Show All Outcome Measures

1. Primary:

Complete Normalization [ Time Frame: 6 weeks ]

Show Outcome Measure 1

2. Secondary:

Complete Normalization, Including Treatment Failures [ Time Frame: 6 weeks ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

Limitations and Caveats

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.

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:

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.

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