Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis (Xolair CRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Ellen Dutta, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01066104
First received: February 8, 2010
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Chronic Rhinosinusitis
Drug: Xolair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: December 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Xolair placebo Drug: Xolair
two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Active Comparator: Xolair (omalizumab) Drug: Xolair
two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066104

Contacts
Contact: Alisa K Brennan, BS 617-726-6376 abrennan3@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Ellen J Dutta, MD         
Sub-Investigator: Daniel L Hamilos, MD         
Sub-Investigator: Martin Ostro, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Genentech
Investigators
Principal Investigator: Ellen J Dutta, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Ellen Dutta, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01066104     History of Changes
Other Study ID Numbers: 2009P001325
Study First Received: February 8, 2010
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 22, 2014