Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Chronic Rhinosinusitis Clinical Trial

— Xolair CRS  

Official title:

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066104
• Other study ID #: 2009P001325
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2010
• Last updated: September 23, 2015
• Start date: December 2009
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Xolair
two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan		4 months	Yes