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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
49
Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20
oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days
nasal saline sprays: 2 sprays each nostril three times a day
daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).
placebo pill to match doxycycline
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Sino-nasal Outcome Test (SNOT 22)
a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome
Time frame: Baseline and 12 weeks
Endoscopic Nasal Polyp Score
0- Absence of nasal polyps 1. Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate 2. Polyps reaching below the lower border of the middle turbinate 3. Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate 4. Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils.
Time frame: Baseline and 12 weeks
Middle Meatus Culture
Culture swab for the presence or absence of microbial growth
Time frame: Baseline and 12 weeks
Subjective Symptom Composite Scoring
A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: "blockage/congestion," "runny nose," "post-nasal discharge," "facial pain/pressure," and "sense of taste/smell." Range of 0 to 25, with higher score reflecting worse symptoms.
Time frame: Baseline and 12 weeks
Visual Analog Scale
The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, \> 3 to and including 7, and \> 7 to and including 10, respectively.
Time frame: Baseline and 12 weeks
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