Treatment of Acute Sinusitis

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Infections; Acute Rhinosinusitis
• Intervention / Treatment: Drug: Acetaminophen; Drug: Amoxicillin; Drug: Dextromethorphan hydrobromide with guaifenesin; Drug: Guaifenesin; Drug: Pseudoephedrine Sustained Action; Drug: Saline spray (0.65%)

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments	Drug: Acetaminophen; Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever; Other Names: Tylenol; Drug: Amoxicillin; Intervention drug: Dose: 500mg tid for 10 days; Other Names: Amoxil; Drug: Dextromethorphan hydrobromide with guaifenesin; Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough; Other Names: Robitussin; Drug: Guaifenesin; Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions; Other Names: Mucinex OTC; Drug: Pseudoephedrine Sustained Action; Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion; Other Names: Sudafed; Drug: Saline spray (0.65%); Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion; Other Names: Ocean Nasal Spray
Placebo Comparator: Symptomatic treatments only; Placebo for 10 days in addition to symptomatic treatments	Drug: Acetaminophen; Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever; Other Names: Tylenol; Drug: Dextromethorphan hydrobromide with guaifenesin; Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough; Other Names: Robitussin; Drug: Guaifenesin; Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions; Other Names: Mucinex OTC; Drug: Pseudoephedrine Sustained Action; Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion; Other Names: Sudafed; Drug: Saline spray (0.65%); Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion; Other Names: Ocean Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3	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).	4 days

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

General Publications

• Garbutt JM, Banister C, Spitznagel E, Piccirillo JF. Amoxicillin for acute rhinosinusitis: a randomized controlled trial. JAMA. 2012 Feb 15;307(7):685-92. doi: 10.1001/jama.2012.138.
• Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2011 Aug;137(8):792-7. doi: 10.1001/archoto.2011.120.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 14, 2006
• First Submitted That Met QC Criteria: September 14, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Estimate): December 28, 2012
• Last Update Submitted That Met QC Criteria: December 24, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: rhinosinusitis, sinusitis, amoxicillin
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Antipyretics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anti-Bacterial Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Antitussive Agents; Sympathomimetics; Expectorants; Vasoconstrictor Agents; Nasal Decongestants; Acetaminophen; Dextromethorphan; Amoxicillin; Ephedrine; Pseudoephedrine; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
• Other Study ID Numbers: 05-0140; U01AI064655-01A1 (U.S. NIH Grant/Contract)