NCT00377403

Treatment of Acute Sinusitis

Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.

Detailed description

The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status, symptoms, disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70 years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative instrument. Secondary outcomes include change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making.

Conditions

• Acute Respiratory Infections
• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Acetaminophen	Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever
DRUG	Amoxicillin	Intervention drug: Dose: 500mg tid for 10 days
DRUG	Dextromethorphan hydrobromide with guaifenesin	Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough
DRUG	Guaifenesin	Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions
DRUG	Pseudoephedrine Sustained Action	Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion
DRUG	Saline spray (0.65%)	Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-05-01
• Completion: 2010-08-01
• First posted: 2006-09-18
• Last updated: 2012-12-28
• Results posted: 2011-06-29

Locations

1 site across 1 country: United States