Treatment of Acute Sinusitis - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine 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 (10mg/5ml) with guaifenesin (100mg/5ml) Drug: Mucinex OTC (guaifenesin) Drug: Pseudoephedrine Sustained Action Drug: Saline spray (0.65%)	Phase IV

MedlinePlus related topics: Sinusitis

Drug Information available for: Sodium chloride Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Acetaminophen Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)

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

Primary Outcome Measures:

SNOT-16 to measure disease-specific quality of life [ Time Frame: Days 0, 3, 7, 10 and 28. ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention Arm: Experimental Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments	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 (10mg/5ml) with guaifenesin (100mg/5ml) Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough Drug: Mucinex OTC (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
Symptomatic treatments only: Placebo Comparator Placebo for 10 days in addition to symptomatic treatments	Drug: Acetaminophen Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever Drug: Dextromethorphan hydrobromide (10mg/5ml) with guaifenesin (100mg/5ml) Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough Drug: Mucinex OTC (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

Arms

Assigned Interventions

Intervention Arm: Experimental

Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments

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 (10mg/5ml) with guaifenesin (100mg/5ml)

Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough

Drug: Mucinex OTC (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

Symptomatic treatments only: Placebo Comparator

Placebo for 10 days in addition to symptomatic treatments

Drug: Acetaminophen

Symptomatic treatment:

Dose: 500mg every 4 to 6 hours for pain or fever

Drug: Dextromethorphan hydrobromide (10mg/5ml) with guaifenesin (100mg/5ml)

Symptomatic treatment:

Dose: 10mls every 4 to 6 hours for cough

Drug: Mucinex OTC (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

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

Contacts

Contact: Jane Garbutt

(314) 454-8613

Locations

United States, Missouri
Washington University in St. Louis	Recruiting
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

Responsible Party:	Washington University School of Medicine ( Jane Garbutt, MBChB )
Study ID Numbers:	05-0140
Study First Received:	September 14, 2006
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00377403
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

rhinosinusitis, sinusitis, amoxicillin

Study placed in the following topic categories:

Pseudoephedrine
Excitatory Amino Acids
Amoxicillin
Otorhinolaryngologic Diseases
Sinusitis
Naphazoline
Oxymetazoline
Respiratory Tract Infections

Respiratory Tract Diseases
Phenylephrine
Guaifenesin
Dextromethorphan
Ephedrine
Phenylpropanolamine
Acetaminophen

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Paranasal Sinus Diseases
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Infection
Adrenergic Agonists
Nasal Decongestants
Anti-Bacterial Agents
Sensory System Agents
Therapeutic Uses

Vasoconstrictor Agents
Appetite Depressants
Analgesics
Excitatory Amino Acid Antagonists
Adrenergic alpha-Agonists
Sympathomimetics
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nose Diseases
Anti-Obesity Agents
Mydriatics
Autonomic Agents

ClinicalTrials.gov processed this record on January 15, 2009