Treatment of Acute Sinusitis - Full Text View

Sponsor:	Washington University School of Medicine
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00377403

Purpose

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.

Condition	Intervention	Phase
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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Sinusitis

Drug Information available for: Ephedrine Hydrochloride Phenylpropanolamine Dextromethorphan hydrochloride Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Triaminic Guaifenesin Acetaminophen CT 2584 Levomethorphan Dextromethorphan Phenylpropanolamine hydrochloride Ephedrine Pseudoephedrine hydrochloride Racemethorphan Naphazoline hydrochloride Naphazoline Dextromethorphan hydrobromide Pseudoephedrine Sulfate

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 [ Time Frame: 4 days ] [ Designated as safety issue: No ]
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).

Enrollment:	172
Study Start Date:	October 2006
Study Completion Date:	August 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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	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

Arms

Assigned Interventions

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 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

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377403

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Jane Garbutt, MB, ChB

Washington University School of Medicine

More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Jane Garbutt, MBChB, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00377403 History of Changes
Other Study ID Numbers:	05-0140, U01AI064655-01A1
Study First Received:	September 14, 2006
Results First Received:	March 31, 2011
Last Updated:	June 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

rhinosinusitis, sinusitis, amoxicillin

Additional relevant MeSH terms:

Respiratory Tract Infections
Sinusitis
Infection
Respiratory Tract Diseases
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Acetaminophen
Dextromethorphan
Phenylpropanolamine
Ephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Pseudoephedrine
Amoxicillin
Naphazoline

Guaifenesin
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012