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Treatment of Acute Sinusitis

Primary Purpose

Acute Respiratory Infections, Acute Rhinosinusitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen

Amoxicillin

Dextromethorphan hydrobromide with guaifenesin

Guaifenesin

Pseudoephedrine Sustained Action

Saline spray (0.65%)

About this trial

This is an interventional treatment trial for Acute Respiratory Infections focused on measuring rhinosinusitis, sinusitis, amoxicillin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Arm

Symptomatic treatments only

Arm Description

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

Placebo for 10 days in addition to symptomatic treatments

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00377403

First Posted

September 14, 2006

Last Updated

December 24, 2012

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00377403

Brief Title

Treatment of Acute Sinusitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Infections, Acute Rhinosinusitis

Keywords

rhinosinusitis, sinusitis, amoxicillin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Symptomatic treatments only

Arm Type

Placebo Comparator

Arm Description

Placebo for 10 days in addition to symptomatic treatments

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Other Intervention Name(s)

Tylenol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Other Intervention Name(s)

Amoxil

Intervention Description

Intervention drug: Dose: 500mg tid for 10 days

Intervention Type

Drug

Intervention Name(s)

Dextromethorphan hydrobromide with guaifenesin

Other Intervention Name(s)

Robitussin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Guaifenesin

Other Intervention Name(s)

Mucinex OTC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pseudoephedrine Sustained Action

Other Intervention Name(s)

Sudafed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline spray (0.65%)

Other Intervention Name(s)

Ocean Nasal Spray

Intervention Description

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

Primary Outcome Measure Information:

Title

SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3

Description

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Garbutt, MB, ChB

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University in St. Louis

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22337680

Citation

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.

Results Reference

derived

PubMed Identifier

21844413

Citation

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.

Results Reference

derived

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Treatment of Acute Sinusitis

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