Treatment of Acute Sinusitis
Condition: Acute Respiratory Infections; Acute Rhinosinusitis
MeSH terms: Respiratory Tract Infections
Intervention: Acetaminophen; Amoxicillin; Dextromethorphan hydrobromide with guaifenesin; Guaifenesin; Pseudoephedrine Sustained Action; Saline spray (0.65%)
Intervention description: Symptomatic treatment:
Dose: 500mg every 4 to 6 hours for pain or fever; Intervention drug:
Dose: 500mg tid for 10 days; Symptomatic treatment:
Dose: 10mls every 4 to 6 hours for cough; Symptomatic treatment:
Dose: 600mg every 12 hours to thin secretions; Symptomatic treatment:
Dose: 120mg every 12 hours for nasal congestion; Symptomatic treatment:
Dose: 2 squeezes per nostril as needed for nasal congestion
Intervention MeSH terms: Acetaminophen; Amoxicillin; Phenylpropanolamine; Pseudoephedrine; Ephedrine; Dextromethorphan; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: rhinosinusitis, sinusitis, amoxicillin

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject must be male or female, and between the ages of 18 and 70 years old.

          2. The subject must have symptoms of acute bacterial rhinosinusitis.

          3. The subject must be attending a participating primary care practice in the community.

          4. The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as
             moderate, severe, or very severe.

          5. The subject must have access to a phone.

        Exclusion Criteria:

          1. The subject is less than 18 years old or more than 70 years old.

          2. The subject has very mild or mild symptom severity assessed by self report.

          3. The subject has an allergy to penicillin or amoxicillin.

          4. The subject has received antibiotic therapy within the past 4 weeks (including chronic
             treatment for acne and low dose prophylactic treatment).

          5. The subject has complications of sinusitis (facial edema, cellulitis, or orbital,
             meningeal or cerebral signs).

          6. The subject is thought to require intravenous antibiotics or hospital admission.

          7. The subject is pregnant. (This will be assessed by self-report. A pregnancy test will
             not be required).

          8. The subject has a comorbidity that may impair their immune response (such as
             immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation
             treatment).

          9. The subject has cystic fibrosis.

         10. The subject has Type I diabetes or is taking insulin to treat diabetes.

         11. The subject had prior sinus surgery.

         12. The subject requires an antibiotic for a concurrent condition such as an ear
             infection.

         13. The subject is not able to complete the study protocol because of language barriers,
             lack of telephone access, or other issues.

         14. Any other condition that the provider feels may interfere with the study.