Trial · NCT00377403
Treatment of Acute Sinusitis
NCT00377403, Phase 4, Completed, Washington University School of Medicine; results first posted 2011-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Acute Sinusitis. Trials, record NCT00377403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Acute Sinusitis
- NCT number
- NCT00377403
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 172 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Acute Respiratory Infections, Acute Rhinosinusitis
- Interventions
- Acetaminophen, Amoxicillin, Dextromethorphan hydrobromide with guaifenesin, Guaifenesin, Pseudoephedrine Sustained Action, Saline spray (0.65%)
- First posted
- 2006-09-18
- Last updated
- 2012-12-28
- Results first posted
- 2011-06-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 | 4 days | The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 | 4 days | We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 | Intervention Arm | 1.12 | Standard Deviation 0.54 | Units on a scale | |
| SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 | Symptomatic Treatments Only | 1.14 | Standard Deviation 0.55 | Units on a scale |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 85 | |
| Overall Study | STARTED | Symptomatic Treatments Only | 81 | |
| Overall Study | Day -3 Assessment | Intervention Arm | 81 | |
| Overall Study | Day -3 Assessment | Symptomatic Treatments Only | 74 | |
| Overall Study | Day 7 Assessment | Intervention Arm | 80 | |
| Overall Study | Day 7 Assessment | Symptomatic Treatments Only | 75 | |
| Overall Study | Day 10 Assessment | Intervention Arm | 81 | |
| Overall Study | Day 10 Assessment | Symptomatic Treatments Only | 71 | |
| Overall Study | Day 28 Assessment | Intervention Arm | 82 | |
| Overall Study | Day 28 Assessment | Symptomatic Treatments Only | 77 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other non-serious adverse events | General disorders | Intervention Arm | 39 | 85 | 39 |
| other | Other non-serious adverse events | General disorders | Symptomatic Treatments Only | 36 | 81 | 36 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | ||
| Total, all-cause mortality | Symptomatic Treatments Only | ||
| Total, other adverse events | Intervention Arm | 39 | 85 |
| Total, other adverse events | Symptomatic Treatments Only | 36 | 81 |
| Total, serious adverse events | Intervention Arm | 0 | 85 |
| Total, serious adverse events | Symptomatic Treatments Only | 0 | 81 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI064655 | RCT to evaluate guidelines for acute rhinosinusitis | GARBUTT, JANE M | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intervention Arm vs Symptomatic Treatments Only: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00377403
GET https://conductscience.org/api/trials/v1/NCT00377403/registered