Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT01066104
• Date of registration: 08/02/2010
• Primary sponsor: Massachusetts General Hospital
• Public title: Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis Xolair CRS
• Scientific title: Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
• Date of first enrolment: December 2009
• Target sample size: 35
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01066104
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Alisa K Brennan, BS

• Name: Ellen J Dutta, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Rhinosinusitis

Intervention(s)

Drug: Xolair

Primary Outcome(s)

Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan [Time Frame: 4 months]

Secondary ID(s)

2009P001325

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech