Symptom Improvement

Improvement of symptoms will be assessed using the Modified Sino-Nasal Outcome Test (mSNOT-16), a disease-specific quality of life questionnaire. Sixteen sinus symptoms are self-assessed on a 0-3 point scale, with 0=No Problem, 1=Mild or Slight Problem, 2=Moderate Problem, 3=Severe Problem. The mean of the total score is used to assess symptom severity. Daily measures will be collected both in Phase 1 and Phase 2.

Change from Day 1 to Day 3 in Phase 2; differences in longitudinal trends across groups during Phase 2

Percent improved beyond minimal clinically important difference

Percent of patients who improved more than 0.5; improvement of symptoms will be assessed using the Modified Sino-Nasal Outcome Test (mSNOT-16), a disease-specific quality of life questionnaire. Sixteen sinus symptoms are self-assessed on a 0-3 point scale, with 0=No Problem, 1=Mild or Slight Problem, 2=Moderate Problem, 3=Severe Problem.

Phase 1: Baseline to Day 9; Phase 2: Day 1 to Day 3

Patient non-randomization rate

Percentage of patients who were enrolled in Phase 1 but did not proceed to randomization because they reported their condition had improved. This is determined by the patient at the Day 9 assessment, by decreased mSNOT-16 scores from baseline, or no longer reports symptoms listed in the inclusion criteria.

Phase 1: baseline to Day 9

Supportive care

Types and frequency of supportive care used.

Phase 1: Baseline to Day 9; Phase 1: Days 1, 3, 5, 7, 10, 14

Work Productivity and Activity Impairment Questionnaire

Work and activity impairment due to acute sinusitis; the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem 2.0 is a 6-question self-reported questionnaire on the effects of sinus symptoms on the amount of absenteeism (percent work time missed), presenteeism (percent impairment while working), overall work impairment, and daily activity impairment. Higher percentages indicate greater impairment and less productivity (scale 0-100%).

Phase 1: Baseline, Day 9 day; Phase 2: Days 1, 7, and 14

Global Rating of Improvement as Quality of Life

Self-assessment of current sinus symptoms at each follow-up interview using a 6-point categorical scale (1=no symptoms, 2=a lot better, 3=a little better, 4=the same, 5=a little worse, or 6=a lot worse).

Phase 1: Baseline, Day 9; Phase 2: Days 1, 7, and 14

Symptomatic care

Use patterns of over-the-counter medicines or supplements.

Phase 1: daily; Phase 2: daily

Adverse events

Adverse events reported during a follow-up or on the diary. Events are graded form 1-5 using the NCI Common Terminology Criteria for Adverse Events.

Phase 1: daily; Phase 2: daily

Adherence

Self-reported adherence to study pill and nasal spray are calculated by \[number of doses taken\]/\[prescribed number of doses\] x 100, over the 7-day intervention period.

Phase 2: Days 1-7

Prevalence of double-sickening

Worsening of symptoms after an initial improvement.

Direct randomization to Phase 2