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

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total Total of all reporting groups

Baseline Measures
   Intervention Arm   Symptomatic Treatments Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   81   166 
[Units: Years]
Median (Full Range)
 (18 to 69) 
 (18 to 66) 
 (18 to 69) 
[Units: Participants]
Female   54   52   106 
Male   31   29   60 

  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