Trial Outcomes & Findings for Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays (NCT NCT00279916)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-05-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45	46
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triamcinolone Acetonide n=45 Participants 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 n=46 Participants 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 n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=99 Participants	18 Participants n=107 Participants	34 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=99 Participants	12 Participants n=107 Participants	30 Participants n=206 Participants
Age, Categorical >=65 years	11 Participants n=99 Participants	16 Participants n=107 Participants	27 Participants n=206 Participants
Age, Continuous	41.4 years STANDARD_DEVIATION 28.4 • n=99 Participants	42.0 years STANDARD_DEVIATION 30.8 • n=107 Participants	41.7 years STANDARD_DEVIATION 29.5 • n=206 Participants
Sex: Female, Male Female	30 Participants n=99 Participants	16 Participants n=107 Participants	46 Participants n=206 Participants
Sex: Female, Male Male	15 Participants n=99 Participants	30 Participants n=107 Participants	45 Participants n=206 Participants
Tympanogram type in worst ear A; peak pressure under -100 kPa	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Tympanogram type in worst ear B; non-peaked or flat pressure	17 participants n=99 Participants	16 participants n=107 Participants	33 participants n=206 Participants
Tympanogram type in worst ear C; peaked pressure greater than -100 kPa	28 participants n=99 Participants	30 participants n=107 Participants	58 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide n=37 Participants 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 n=37 Participants 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.
Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment	7 participants	12 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide n=37 Participants 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 n=37 Participants 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.
Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution	5 participants	9 participants

SECONDARY outcome

Timeframe: baseline, 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide n=37 Participants 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 n=37 Participants 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.
Per-Ear Treatment Outcome Initial Tympanogram of Type B or C	55 ears	57 ears
Per-Ear Treatment Outcome 6 weeks Complete Normalization (Type A)	12 ears	20 ears

SECONDARY outcome

Timeframe: baseline, 6 weeks

Population: 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.