Conditions: Polyp of Nasal Sinus
Keywords: doxycycline oral methylprednisone sinusitis with nasal polyps
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief 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.

Detailed description:
An eligible patient may be treated with either doxycycline and oral steroids OR placebo (sugar pill) and oral steroids for three weeks. Volunteers will participate in the study for to 12 weeks, and will have 4 research visits of 1 hour duration. At each study visit, the patient will under go an endoscopic evaluation and asked to complete a questionnaire describing symptoms. There is no additional cost to be enrolled in the study.

Arms:
arm 1: Doxycycline plus oral methylprednisolone and nasal saline sprays arm 2: placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.

Interventions: intervention 1: Doxycycline intervention 2: methylprednisolone intervention 3: nasal saline spray intervention 4: Flonase intervention 5: sugar pill
Intervention descriptions: intervention 1: Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20 intervention 2: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days intervention 3: nasal saline sprays: 2 sprays each nostril three times a day intervention 4: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily). intervention 5: placebo pill to match doxycycline

Protocol document: