Treatment of Acute Sinusitis

This study has been completed.

Study NCT00377403 Information provided by Washington University School of Medicine

First Received on September 14, 2006. Last Updated on June 3, 2011 History of Changes

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
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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

	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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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

Baseline Measures

	Intervention Arm	Symptomatic Treatments Only	Total
Number of Participants [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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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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Results Point of Contact:

Name/Title: Jane Garbut,MD
Organization: Washington University in St Louis
phone: 314-454-8613
e-mail: jgarbutt@dom.wustl.edu

No publications provided by Washington University School of Medicine

Publications automatically indexed to this study:

Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2011 Aug;137(8):792-7.

Responsible Party:	Jane Garbutt, MBChB, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00377403 History of Changes
Other Study ID Numbers:	05-0140, U01AI064655-01A1
Study First Received:	September 14, 2006
Results First Received:	March 31, 2011
Last Updated:	June 3, 2011
Health Authority:	United States: Institutional Review Board