Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
Condition: Chronic Rhinosinusitis; Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Intervention: Xolair placebo; Xolair (omalizumab)
Intervention description: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level); two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are doing this research study to learn more about a drug called Xolair
      (omalizumab). The investigators want to see if it is an effective treatment for chronic
      rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make
      nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are
      abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your
      nose). The investigators also want to find out if it is safe to use (whether it causes side
      effects).
    

Eligibility criteria:

        Inclusion criteria

          1. Subjects will be male or female and 18 years of age or older.

          2. Females of childbearing potential will use approved contraception, defined as the use
             of hormonal (oral, injectable, or implantable) or barrier-method contraceptives,
             intrauterine device, or history of bilateral tubal ligation. Women who have undergone
             a total hysterectomy or are two years post-menopausal will also be eligible.

          3. Subjects must meet the criteria for CRS, namely they must have (1) at least two major
             criteria (facial pain/pressure or headache, nasal congestion, anterior or posterior
             nasal drainage, hyposmia/anosmia) for at least 3 consecutive months; (2) an abnormal
             sinus CT scan in at least two sinus areas documented within 3 months of entry or
             endoscopic evidence of disease.

          4. Subjects must have bilateral polypoid disease demonstrated either by CT or endoscopy
             with evidence of nasal polyps or polypoid mucosa on examination in at least two of the
             following areas: right maxillary sinus, left maxillary sinus, right anterior ethmoid
             sinus, left anterior ethmoid sinus plus a minimal polyp/polypoid score of 4 on the
             baseline rhinoscopic examination. (Nasal polyps are defined as discreet polyps visible
             in the middle meatus area.)

          5. Evidence or history of positive skin test or in vitro reactivity to a perennial
             aeroallergen.

          6. Subjects must meet the study drug-dosing table eligibility criteria (serum IgE level ≥
             30 to ≤ 1500 IU/mL and body weight ≥ 30 to ≤ 150 kg).

          7. Subjects must have a minimum total symptom score of 5 (range of scores 0-15) at
             baseline.

        Exclusion criteria

          1. Females who are pregnant or nursing, or females of childbearing potential not using
             approved contraception, defined as the use of hormonal (oral, injectable, or
             implantable) or barrier-method contraceptives, intrauterine device, or history of
             bilateral tubal ligation.

          2. Subjects who do not meet the clinical criteria for Xolair (omalizumab)

          3. Subjects who are taking a beta blocker.

          4. Known sensitivity to Xolair (omalizumab).

          5. Subjects who have evidence of acute bacterial exacerbation of rhinosinusitis requiring
             antibiotic therapy manifesting as gross purulent drainage on physical examination or
             untreated air/fluid level on sinus CT scan.

          6. Subjects who have received antibiotics within 3 weeks of the screening visit.

          7. Subjects with uncontrolled moderate to severe asthma who have experienced a recent
             exacerbation requiring use of systemic steroids burst within 6 weeks of study
             enrollment. Subjects who are receiving a maintenance dose of Prednisone of 5 mg/day or
             less will be allowed provided the dose of Prednisone is not changed during the study.

          8. Subjects with a history of uncontrolled recurrent epistaxis within the past 6 weeks.

          9. Subjects with a history of hypogammaglobulinemia, cystic fibrosis, bronchiectasis,
             immotile cilia syndrome, systemic granulomatous disease, malignancy (or strong family
             history of malignancy), or history of recent cocaine use.

         10. Cigarette smoking in the past 3 years.

         11. Subjects with other serious medical problems, such as Grade III/IV cardiac problems as
             defined by the New York Heart Association Criteria within 6 months of study, severe
             and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal or
             liver disease, infection with HIV or other active uncontrolled infection). Subjects
             who have had a major surgery within 3 months of the screening visit.

         12. Subjects with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent.

         13. Subjects with alcohol or drug abuse/dependence within the past 3 months.

         14. Subjects with persistent abnormalities of hepatic, renal or hematologic function,
             defined as the following: total bilirubin, SGOT and SGPT > 1.5 x upper limit of
             normal, creatinine > 2.0 x upper limit of normal, absolute neutrophil count < 1.5 x
             109/L, platelets < 100 x 109/L.

         15. Subjects who have used oral or systemic steroid burst within 6 weeks of study
             enrollment.

         16. Use of any other investigational agent in the 30 days prior to enrollment.