Trial Outcomes & Findings for Treatment of Acute Sinusitis (NCT NCT00377403)

Last Updated: 2012-12-28

Results Overview

The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

172 participants

Primary outcome timeframe

4 days

Results posted on

2012-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	Symptomatic Treatments Only Placebo for 10 days in addition to symptomatic treatments
Overall Study STARTED	85	81
Overall Study Day -3 Assessment	81	74
Overall Study Day 7 Assessment	80	75
Overall Study Day 10 Assessment	81	71
Overall Study Day 28 Assessment	82	77
Overall Study COMPLETED	81	74
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	Symptomatic Treatments Only Placebo for 10 days in addition to symptomatic treatments
Overall Study Unable to contact for telephone intervie	4	7

Baseline Characteristics

Treatment of Acute Sinusitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=85 Participants Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	Symptomatic Treatments Only n=81 Participants Placebo for 10 days in addition to symptomatic treatments	Total n=166 Participants Total of all reporting groups
Age Continuous	32 years n=5 Participants	31 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects.

Outcome measures

Outcome measures
Measure	Intervention Arm n=81 Participants Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	Symptomatic Treatments Only n=74 Participants Placebo for 10 days in addition to symptomatic treatments
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3	1.12 Units on a scale Standard Deviation 0.54	1.14 Units on a scale Standard Deviation 0.55

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Symptomatic Treatments Only

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Arm n=85 participants at risk Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	Symptomatic Treatments Only n=81 participants at risk Placebo for 10 days in addition to symptomatic treatments
General disorders Other non-serious adverse events	45.9% 39/85 • Number of events 39	44.4% 36/81 • Number of events 36

Additional Information

Jane Garbut,MD

Washington University in St Louis

Phone: 314-454-8613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place