Treatment of Acute Sinusitis
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ClinicalTrials.gov Identifier: NCT00377403 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Results First Posted : June 29, 2011
Last Update Posted : December 28, 2012
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Condition or disease | Intervention/treatment | Phase |
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Acute Respiratory Infections Acute Rhinosinusitis | Drug: Acetaminophen Drug: Amoxicillin Drug: Dextromethorphan hydrobromide with guaifenesin Drug: Guaifenesin Drug: Pseudoephedrine Sustained Action Drug: Saline spray (0.65%) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study) |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | August 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention Arm
Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments
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Drug: Acetaminophen
Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever Other Name: Tylenol Drug: Amoxicillin Intervention drug: Dose: 500mg tid for 10 days Other Name: Amoxil Drug: Dextromethorphan hydrobromide with guaifenesin Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough Other Name: Robitussin Drug: Guaifenesin Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions Other Name: Mucinex OTC Drug: Pseudoephedrine Sustained Action Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion Other Name: Sudafed Drug: Saline spray (0.65%) Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion Other Name: Ocean Nasal Spray |
Placebo Comparator: Symptomatic treatments only
Placebo for 10 days in addition to symptomatic treatments
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Drug: Acetaminophen
Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever Other Name: Tylenol Drug: Dextromethorphan hydrobromide with guaifenesin Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough Other Name: Robitussin Drug: Guaifenesin Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions Other Name: Mucinex OTC Drug: Pseudoephedrine Sustained Action Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion Other Name: Sudafed Drug: Saline spray (0.65%) Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion Other Name: Ocean Nasal Spray |
- SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 [ Time Frame: 4 days ]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).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject must be male or female, and between the ages of 18 and 70 years old.
- The subject must have symptoms of acute bacterial rhinosinusitis.
- The subject must be attending a participating primary care practice in the community.
- The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
- The subject must have access to a phone.
Exclusion Criteria:
- The subject is less than 18 years old or more than 70 years old.
- The subject has very mild or mild symptom severity assessed by self report.
- The subject has an allergy to penicillin or amoxicillin.
- The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
- The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- The subject is thought to require intravenous antibiotics or hospital admission.
- The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).
- The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- The subject has cystic fibrosis.
- The subject has Type I diabetes or is taking insulin to treat diabetes.
- The subject had prior sinus surgery.
- The subject requires an antibiotic for a concurrent condition such as an ear infection.
- The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.
- Any other condition that the provider feels may interfere with the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377403
United States, Missouri | |
Washington University in St. Louis | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Jane Garbutt, MB, ChB | Washington University School of Medicine |
Responsible Party: | Jane Garbutt, MD, Associate Professor, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00377403 |
Other Study ID Numbers: |
05-0140 U01AI064655-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | September 18, 2006 Key Record Dates |
Results First Posted: | June 29, 2011 |
Last Update Posted: | December 28, 2012 |
Last Verified: | December 2012 |
rhinosinusitis, sinusitis, amoxicillin |
Respiratory Tract Infections Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Infection Acetaminophen Amoxicillin Phenylpropanolamine Pseudoephedrine Ephedrine Dextromethorphan Guaifenesin Chlorpheniramine, phenylpropanolamine drug combination |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Bacterial Agents Anti-Infective Agents Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents |