Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Treatment of Acute Sinusitis

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00377403
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;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
No text entered.

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
  Description
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] 
NOT COMPLETED   4   7 
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
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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.
No text entered.

Reporting Groups
  Description
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 
Age 
[Units: Years]
Median (Full Range)
 32 
 (18 to 69) 
 31 
 (18 to 66) 
 32 
 (18 to 69) 
Gender 
[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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
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

Other Adverse Events
    Intervention Arm   Symptomatic Treatments Only
Total, other (not including serious) adverse events     
# participants affected / at risk   39/85 (45.88%)   36/81 (44.44%) 
General disorders     
Other non-serious adverse events     
# participants affected / at risk   39/85 (45.88%)   36/81 (44.44%) 
# events   39   36 
* Events were collected by non-systematic assessment



  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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  More Information