Chronic RhinosinusitisPhase 3NCT01988779
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
A Phase 3 study testing oral levofloxacin and nebulized levofloxacin in people with Chronic Rhinosinusitis, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- oral levofloxacin and nebulized levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18).
- Diagnosis of CRS.
- Worsening sinonasal symptoms.
- Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
- English speaking.
- Open sinuses (open middle meatus bilaterally; determined on endoscopy).
- Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.
Who cannot join
- Patients < 18 years of age.
- Treatment with systemic or topical antibiotics within the last 1 month.
- Pregnant women.
- Non-English speaking persons.
- Systemically ill at initial visit necessitating treatment prior to culture data.
- Allergies to chosen susceptible antibiotics.
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- Sinonasal culture with less than 1+ growth.
- Multiple organisms grown on culture that are not sensitive to a single antibiotic.
- Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
- Patients with immunodeficiencies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, 14642
About this study
Official title: Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.
Read the detailed description
See brief summary.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- oral levofloxacin, nebulized levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral levofloxacinDrug
nebulized levofloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| oral placebo with nebulized intranasal levofloxacin | Active comparator | Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days Receives: Drug: oral levofloxacin; Drug: nebulized levofloxacin |
| oral antibiotics with nebulized intranasal placebo | Active comparator | Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. Receives: Drug: oral levofloxacin; Drug: nebulized levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rhinosinusitis Disability Index (RSDI) Score
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
Measured: Baseline and 14 days after treatment
Secondary outcomes (4)
Change in Sino-nasal Outcome Test (SNOT-22) Score
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
Measured: Baseline and 14 days after treatment
Change in Bilateral Endoscopy Findings Using POSE Score
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.
Measured: Baseline and 14 days after treatment
Number of Participants With Post-treatment Culture Negativity
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
Measured: 14 days after treatment
Mean Change in the Total Bacterial Community
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.
Measured: Baseline and 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion11 Sep 2017
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Xing Man, University of Rochester
- Investigators
- Li-Xing Man, MD, MPA, Msc, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988779
- Sponsor's protocol ID
- 45566
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2013
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
- ClinicalTrials.gov ID
- NCT01988779
- Acronym / sponsor ID
- 45566
- Conditions
- Chronic Rhinosinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.
Detailed description
See brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral placebo with nebulized intranasal levofloxacin | Active comparator | Drug: oral levofloxacin, Drug: nebulized levofloxacinPlacebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days |
| oral antibiotics with nebulized intranasal placebo | Active comparator | Drug: oral levofloxacin, Drug: nebulized levofloxacinLevofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (age ≥ 18).
- Diagnosis of CRS.
- Worsening sinonasal symptoms.
- Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
- English speaking.
Key exclusion criteria (10 listed)
- Patients < 18 years of age.
- Treatment with systemic or topical antibiotics within the last 1 month.
- Pregnant women.
- Non-English speaking persons.
- Systemically ill at initial visit necessitating treatment prior to culture data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral levofloxacin | Drug | oral antibiotics with nebulized intranasal placebo, oral placebo with nebulized intranasal levofloxacin |
| nebulized levofloxacin | Drug | oral antibiotics with nebulized intranasal placebo, oral placebo with nebulized intranasal levofloxacin |
Primary outcome
Change in Rhinosinusitis Disability Index (RSDI) Score
Time frame: 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
4 secondary outcomes
Change in Sino-nasal Outcome Test (SNOT-22) Score
Time frame: Baseline and 14 days after treatment
Change in Bilateral Endoscopy Findings Using POSE Score
Time frame: Baseline and 14 days after treatment
Number of Participants With Post-treatment Culture Negativity
Time frame: 14 days after treatment
Mean Change in the Total Bacterial Community
Time frame: Baseline and 14 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Xing Man, MD, MPA, Msc principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral levofloxacin and nebulized levofloxacin in people with Chronic Rhinosinusitis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rhinosinusitis Disability Index (RSDI) Score (time frame: Baseline and 14 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.