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Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT02569437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-01-09

Study results available
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Summary

The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral steroids are the mainstay of medical management for patients with CRSwNP. However, recent studies have shown that doxycycline helps improve symptoms as well by reducing inflammation and killing common bacteria that can cause symptoms. This study is the first to evaluate this combination regimen.

Conditions

  • Polyp of Nasal Sinus

Interventions

DRUG

Doxycycline

Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20

DRUG

methylprednisolone

oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days

DRUG

nasal saline spray

nasal saline sprays: 2 sprays each nostril three times a day

DRUG

Flonase

daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).

DRUG

sugar pill

placebo pill to match doxycycline

Sponsors & Collaborators

Principal Investigators

  • Benjamin D Malkin, MD · Icahns School of Medicine at Mount Sinai

  • Satish Govindaraj, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-08-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02569437 on ClinicalTrials.gov