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Treatment of Acute Sinusitis

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine Identifier:
First received: September 14, 2006
Last updated: December 24, 2012
Last verified: December 2012
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Respiratory Infections
Acute Rhinosinusitis
Interventions: Drug: Acetaminophen
Drug: Amoxicillin
Drug: Dextromethorphan hydrobromide with guaifenesin
Drug: Guaifenesin
Drug: Pseudoephedrine Sustained Action
Drug: Saline spray (0.65%)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Intervention Arm Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
Symptomatic Treatments Only Placebo for 10 days in addition to symptomatic treatments

Participant Flow:   Overall Study
    Intervention Arm   Symptomatic Treatments Only
STARTED   85   81 
Day -3 Assessment   81   74 
Day 7 Assessment   80   75 
Day 10 Assessment   81   71 
Day 28 Assessment   82   77 
COMPLETED   81 [1]   74 [2] 
Unable to contact for telephone intervie                4                7 
[1] The number varied by day of follow-up from 80 to 82 in the intervention group.
[2] The number varied by day of follow-up from 71 to 77 in the symptomatic treatment only group.

  Baseline Characteristics

  Outcome Measures

1.  Primary:   SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3   [ Time Frame: 4 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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