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Treatment of Acute Sinusitis
This study is ongoing, but not recruiting participants.
First Received: September 14, 2006   Last Updated: July 31, 2009   History of Changes
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 (10mg/5ml) with guaifenesin (100mg/5ml)
Drug: Mucinex OTC (guaifenesin)
Drug: Pseudoephedrine Sustained Action
Drug: Saline spray (0.65%)
 Phase IV

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)

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Sinusitis
Drug Information available for: Phenylpropanolamine Dextromethorphan hydrochloride Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Triaminic Guaifenesin Acetaminophen CT 2584 Levomethorphan Dextromethorphan Phenylpropanolamine hydrochloride Racemethorphan Naphazoline hydrochloride Naphazoline Dextromethorphan hydrobromide
U.S. FDA Resources

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: August 2009
Estimated Primary Completion Date: August 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

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:

  1. The subject must be male or female, and between the ages of 18 and 70 years old.
  2. The subject must have symptoms of acute bacterial rhinosinusitis.
  3. The subject must be attending a participating primary care practice in the community.
  4. The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
  5. The subject must have access to a phone.

Exclusion Criteria:

  1. The subject is less than 18 years old or more than 70 years old.
  2. The subject has very mild or mild symptom severity assessed by self report.
  3. The subject has an allergy to penicillin or amoxicillin.
  4. The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
  5. The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
  6. The subject is thought to require intravenous antibiotics or hospital admission.
  7. The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).
  8. The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
  9. The subject has cystic fibrosis.
  10. The subject has Type I diabetes or is taking insulin to treat diabetes.
  11. The subject had prior sinus surgery.
  12. The subject requires an antibiotic for a concurrent condition such as an ear infection.
  13. The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.
  14. 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

Responsible Party: Washington University School of Medicine ( Jane Garbutt, MBChB )
Study ID Numbers: 05-0140
Study First Received: September 14, 2006
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00377403     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
rhinosinusitis, sinusitis, amoxicillin

Additional relevant MeSH terms:
Respiratory System Agents
Anti-Infective Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Sinusitis
Infection
Adrenergic Agonists
Nasal Decongestants
Naphazoline
Anti-Bacterial Agents
Respiratory Tract Diseases
 Respiratory Tract Infections
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Appetite Depressants
Phenylpropanolamine
Analgesics
Acetaminophen
Excitatory Amino Acid Antagonists
Pseudoephedrine
Amoxicillin
Adrenergic alpha-Agonists
Otorhinolaryngologic Diseases
Sympathomimetics
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 08, 2010



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