Treatment of Acute Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377403
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : June 29, 2011
Last Update Posted : December 28, 2012
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (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

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

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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  More Information