Doxycycline in Treating Patients With Chronic Rhinosinusitis With Nasal Polyps
Condition: Polyp of Nasal Sinus
MeSH terms: Nasal Polyps; Polyps
Intervention: Doxycycline; methylprednisolone; nasal saline spray; Flonase; sugar pill
Intervention description: 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
Intervention MeSH terms: Fluticasone; Doxycycline; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: doxycycline; oral methylprednisone; sinusitis with nasal polyps

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nasal polyps on nasal endoscopy.

          -  The patient has moderate to severe disease, defined by moderate to severe subjective
             symptoms (a score greater than 3 on a 10-cm VAS).

          -  The patient is at least 18 years old.

          -  The patient is able to understand and give informed consent.

          -  The patient has clinically diagnosed chronic rhinosinusitis with nasal polyps
             according to the AAO-HNS diagnostic criteria: At least 2 of the following
             symptoms/signs:

               -  Mucopurulent drainage (anterior, posterior, or both)

               -  Nasal obstruction (congestion)

               -  Facial pain-pressure-fullness

               -  Decreased sense of smell

               -  and symptoms lasting 12 weeks or longer.

        Exclusion Criteria:

          -  The patient has a history of treatment with oral corticosteroids in the past 4 weeks.
             ,

          -  The patient has cystic fibrosis.

          -  The patient has primary ciliary dyskinesia.

          -  The patient has diabetes.

          -  The patient has had sinus surgery in the past 3 months.

          -  The patient has an allergy to doxycycline or related tetracyclines or glucocorticoids.

          -  The patient is a minor.

          -  The patient is a prisoner.

          -  The patient has a psychiatric illness or developmental delay, which would interfere
             with understanding of the study and provision of informed consent.

          -  The patient is a breastfeeding mother. The effects of the drugs used in this study
             (doxycycline) on breast milk are unknown and thus, these patients will be excluded
             from the study

          -  The patient has a history of HIV or other known cause of immunosuppression, or is
             actively taking immunosuppressive medications due to organ transplantation, rheumatoid
             disease, or other medical conditions.

          -  The patient is on penicillin; antacids containing aluminum, calcium, magnesium, or
             iron; bismuth subsalicylate; barbiturates; carbamazepine; and phenytoin; as well as
             tetracycline and Penthane.

          -  Pregnancy. Doxycycline, a tetracycline, is a known teratogen. For this reason women of
             child-bearing potential are suggested to take a form of contraception for the duration
             that they are taking doxycycline., Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

        Pregnancy Testing. Women of childbearing potential are required to have a negative serum
        pregnancy test (with a sensitivity of at least 25 mIU/mL) prior to the first dose of drug.
        No further pregnancy tests are required since after this visit the patient will no longer
        be taking tetracycline after 3 weeks.

        Women of childbearing potential are defined as follows:

          -  Patients with regular menses

          -  Patients with amenorrhea, irregular cycles, or using a contraceptive method that
             precludes withdrawal bleeding

          -  Women who have had a tubal ligation

        Women are considered not to be of childbearing potential for the following reasons:

          -  The patient has undergone hysterectomy and/or bilateral oophorectomy.

          -  The patient is post-menopausal defined by amenorrhea for at least 1 year in a woman >
             45 years old.