Trial · NCT01988779
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
NCT01988779, Phase 3, Completed, University of Rochester; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations. Trials, record NCT01988779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01988779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
- NCT number
- NCT01988779
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Chronic Rhinosinusitis
- Interventions
- oral levofloxacin, nebulized levofloxacin
- First posted
- 2013-11-20
- Last updated
- 2021-03-24
- Results first posted
- 2019-12-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Rhinosinusitis Disability Index (RSDI) Score | Baseline and 14 days after treatment | The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement |
| Secondary | Change in Sino-nasal Outcome Test (SNOT-22) Score | Baseline and 14 days after treatment | The Sino-nasal outcome test is a 22-item questionnaire completed by the patient or subject. Each item has a value of zero to five, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 110. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement |
| Secondary | Change in Bilateral Endoscopy Findings Using POSE Score | Baseline and 14 days after treatment | The Perioperative Sinus Endoscopy (POSE) instrument is a specific tool to endoscopically assess the sinus cavities of patients who have undergone endoscopic sinus surgery. Each POSE score has a minimum of 0 and a maximum of 16, with a higher score indicating a worse outcome. Here, the Left and Right POSE scores are summed and the difference between baseline and the 14 day after treatment is reported. The change in bilateral POSE score can in principle be -32 to +32, with increased scores indicating worse outcome and negative scores indicating improvement over the treatment period. |
| Secondary | Number of Participants With Post-treatment Culture Negativity | 14 days after treatment | Post-treatment culture negativity, defined as less than 1+ growth of organisms. A subject is counted '1' if both nares are free of bacterial growth, and '0' if growth is 1+ of more |
| Secondary | Mean Change in the Total Bacterial Community | Baseline and 14 days after treatment | The bacterial community was determined using a 16S rRNA quantitative PCR processed using Quantitative Insights into Microbial Ecology (QIIME) software, version 1.8 to yield the number of operational taxonomic units in each subject sample. The count has a minimum of zero with an increasing score indicating a larger number of distinct bacterial species. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Rhinosinusitis Disability Index (RSDI) Score | Baseline and 14 days after treatment | units on a scale | MEAN | |
| SECONDARY | Change in Sino-nasal Outcome Test (SNOT-22) Score | Baseline and 14 days after treatment | units on a scale | MEAN | |
| SECONDARY | Change in Bilateral Endoscopy Findings Using POSE Score | Baseline and 14 days after treatment | units on a scale | MEAN | |
| SECONDARY | Number of Participants With Post-treatment Culture Negativity | 14 days after treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in the Total Bacterial Community | Baseline and 14 days after treatment | Data was only collected on the first consecutive 8 randomized participants and had equal numbers in each group | operational taxonomic units | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Rhinosinusitis Disability Index (RSDI) Score | Oral Placebo With Nebulized Intranasal Levofloxacin | -8.000 | Standard Deviation 29.47 | units on a scale | |
| Change in Rhinosinusitis Disability Index (RSDI) Score | Oral Antibiotics With Nebulized Intranasal Placebo | -14.82 | Standard Deviation 13.49 | units on a scale | |
| Change in Sino-nasal Outcome Test (SNOT-22) Score | Oral Placebo With Nebulized Intranasal Levofloxacin | -2.333 | Standard Deviation 33.02 | units on a scale | |
| Change in Sino-nasal Outcome Test (SNOT-22) Score | Oral Antibiotics With Nebulized Intranasal Placebo | -18.73 | Standard Deviation 12.37 | units on a scale | |
| Change in Bilateral Endoscopy Findings Using POSE Score | Oral Placebo With Nebulized Intranasal Levofloxacin | -2.889 | Standard Deviation 5.442 | units on a scale | |
| Change in Bilateral Endoscopy Findings Using POSE Score | Oral Antibiotics With Nebulized Intranasal Placebo | -4.545 | Standard Deviation 2.806 | units on a scale | |
| Number of Participants With Post-treatment Culture Negativity | Oral Placebo With Nebulized Intranasal Levofloxacin | 5 | Participants | ||
| Number of Participants With Post-treatment Culture Negativity | Oral Antibiotics With Nebulized Intranasal Placebo | 2 | Participants | ||
| Mean Change in the Total Bacterial Community | Oral Placebo With Nebulized Intranasal Levofloxacin | 17.40 | Standard Deviation 9.530 | operational taxonomic units | |
| Mean Change in the Total Bacterial Community | Oral Antibiotics With Nebulized Intranasal Placebo | 6.700 | Standard Deviation 7.404 | operational taxonomic units |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Placebo With Nebulized Intranasal Levofloxacin | 12 | |
| Overall Study | STARTED | Oral Antibiotics With Nebulized Intranasal Placebo | 13 | |
| Overall Study | COMPLETED | Oral Placebo With Nebulized Intranasal Levofloxacin | 9 | |
| Overall Study | COMPLETED | Oral Antibiotics With Nebulized Intranasal Placebo | 11 | |
| Overall Study | NOT COMPLETED | Oral Placebo With Nebulized Intranasal Levofloxacin | 3 | |
| Overall Study | NOT COMPLETED | Oral Antibiotics With Nebulized Intranasal Placebo | 2 |
Source ClinicalTrials.gov
Adverse events14
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 | epistaxis | General disorders | Oral Placebo With Nebulized Intranasal Levofloxacin | 3 | 12 | |
| other | epistaxis | General disorders | Oral Antibiotics With Nebulized Intranasal Placebo | 6 | 13 | |
| other | Fever | General disorders | Oral Placebo With Nebulized Intranasal Levofloxacin | 2 | 12 | |
| other | Fever | General disorders | Oral Antibiotics With Nebulized Intranasal Placebo | 0 | 13 | |
| other | diarrhea | Gastrointestinal disorders | Oral Placebo With Nebulized Intranasal Levofloxacin | 1 | 12 | |
| other | diarrhea | Gastrointestinal disorders | Oral Antibiotics With Nebulized Intranasal Placebo | 3 | 13 | |
| other | joint pain | Musculoskeletal and connective tissue disorders | Oral Placebo With Nebulized Intranasal Levofloxacin | 0 | 12 | |
| other | joint pain | Musculoskeletal and connective tissue disorders | Oral Antibiotics With Nebulized Intranasal Placebo | 1 | 13 | |
| other | bad taste | Gastrointestinal disorders | Oral Placebo With Nebulized Intranasal Levofloxacin | 3 | 12 | |
| other | bad taste | Gastrointestinal disorders | Oral Antibiotics With Nebulized Intranasal Placebo | 3 | 13 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Placebo With Nebulized Intranasal Levofloxacin | 0 | 12 |
| Total, all-cause mortality | Oral Antibiotics With Nebulized Intranasal Placebo | 0 | 13 |
| Total, other adverse events | Oral Placebo With Nebulized Intranasal Levofloxacin | 5 | 12 |
| Total, other adverse events | Oral Antibiotics With Nebulized Intranasal Placebo | 9 | 13 |
| Total, serious adverse events | Oral Placebo With Nebulized Intranasal Levofloxacin | 0 | 12 |
| Total, serious adverse events | Oral Antibiotics With Nebulized Intranasal Placebo | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Placebo With Nebulized Intranasal Levofloxacin vs Oral Antibiotics With Nebulized Intranasal Placebo: deaths from any cause | Trial comparisons |
| Oral Placebo With Nebulized Intranasal Levofloxacin vs Oral Antibiotics With Nebulized Intranasal Placebo: Number of Participants With Post-treatment Culture Negativity | Trial comparisons |
| Oral Placebo With Nebulized Intranasal Levofloxacin vs Oral Antibiotics With Nebulized Intranasal Placebo: serious adverse events | 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/NCT01988779
GET https://conductscience.org/api/trials/v1/NCT01988779/registered