NCT01988779 is a Phase 3 clinical trial of oral levofloxacin in Chronic Rhinosinusitis, sponsored by University of Rochester.

Who is sponsoring NCT01988779?

NCT01988779 is sponsored by University of Rochester.

What drugs are being tested in NCT01988779?

Interventions in NCT01988779: oral levofloxacin, nebulized levofloxacin.

What condition does NCT01988779 study?

NCT01988779 studies Chronic Rhinosinusitis.

Is NCT01988779 still recruiting?

NCT01988779 is currently completed. Last updated 2 March 2021.

Are results published for NCT01988779?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-02 · How we verify

NCT01988779

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations

Completed Phase 3 Results posted Last updated 2 March 2021

What this trial tests

Phase 3 trial testing oral levofloxacin in Chronic Rhinosinusitis in 33 participants. Completed in 31 December 2020.

Timeline

1 October 2013

Primary endpoint
11 September 2017

31 December 2020

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	33
Start date	1 October 2013
Primary completion	11 September 2017
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

oral levofloxacin
nebulized levofloxacin — full drug profile →

Conditions studied

Chronic Rhinosinusitis — all drugs for Chronic Rhinosinusitis →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Chronic Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Chronic Rhinosinusitis

Currently open trials in the same condition.

NCT06920576 — Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal En · Phase 1, PHASE2 · active not recruiting
NCT06457100 — Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Sur · Phase 1, PHASE2 · active not recruiting
NCT07340411 — Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis · Phase 2 · recruiting
NCT05883462 — Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH) · EARLY_PHASE1 · active not recruiting
NCT05935683 — Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis · recruiting

Other University of Rochester trials

Trials by the same sponsor.

NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01988779 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Rochester
Last refreshed: 2 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01988779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing