Treatment of Acute Sinusitis

NCT00377403 | Completed Phase 4 Results DMC

• 2 other identifiers: 05-0140U01AI064655-01A1
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Infections; Acute Rhinosinusitis

Keywords

rhinosinusitis, sinusitis, amoxicillin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments

Drug: Acetaminophen; Drug: Amoxicillin; Drug: Dextromethorphan hydrobromide with guaifenesin; Drug: Guaifenesin; Drug: Pseudoephedrine Sustained Action; Drug: Saline spray (0.65%)

Symptomatic treatments only

PLACEBO COMPARATOR

Placebo for 10 days in addition to symptomatic treatments

Drug: Acetaminophen; Drug: Dextromethorphan hydrobromide with guaifenesin; Drug: Guaifenesin; Drug: Pseudoephedrine Sustained Action; Drug: Saline spray (0.65%)

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Intervention Arm; Symptomatic treatments only

Amoxicillin DRUG

Intervention drug: Dose: 500mg tid for 10 days

Also known as: Amoxil

Intervention Arm

Dextromethorphan hydrobromide with guaifenesin DRUG

Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough

Also known as: Robitussin

Intervention Arm; Symptomatic treatments only

Guaifenesin DRUG

Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions

Also known as: Mucinex OTC

Intervention Arm; Symptomatic treatments only

Pseudoephedrine Sustained Action DRUG

Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion

Also known as: Sudafed

Intervention Arm; Symptomatic treatments only

Saline spray (0.65%) DRUG

Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion

Also known as: Ocean Nasal Spray

Intervention Arm; Symptomatic treatments only

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 22337680 DERIVED

• 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.

  PMID: 21844413 DERIVED

MeSH Terms

Conditions

Rhinosinusitis; Sinusitis

Interventions

Acetaminophen; Amoxicillin; Dextromethorphan; Guaifenesin; Acetylcysteine; Pseudoephedrine

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cysteine; Amino Acids, Sulfur; Amino Acids; Amino Acids, Peptides, and Proteins; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Jane Garbut,MD
• Organization: Washington University in St Louis

jgarbutt@dom.wustl.edu

314-454-8613

Study Officials

• Jane Garbutt, MB, ChB

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2010
• Last Updated: December 28, 2012
• Results First Posted: June 29, 2011

Record last verified: 2012-12

Locations

US (1)