Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis BRIEF 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). 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 CONDITION Chronic Rhinosinusitis PRIMARY OUTCOME Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan 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 ≤ 700 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. (See Total Symptom Score under Procedures) - 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 (defined as FEV1 < 80% with - Asthma Control Test <19 for the week prior to entry), recent exacerbation, or 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 a strong - family history of malignancy), or history of recent cocaine use. - 10. Cigarette smoking in the past 3 years. GENDER: Both MINIMUM AGE: 18 Years MAXIMUM AGE: N/A LOCATION Massachusetts General Hospital. Boston. Massachusetts. 02114. United States. Recruiting. Ellen J Dutta, MD. Principal Investigator. Daniel L Hamilos, MD. Sub-Investigator. Martin Ostro, MD. Sub-Investigator. FIRST RECEIVED February 8, 2010 VERIFICATION DATE February 2010 LAST CHANGED February 9, 2010 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Sponsored by: Massachusetts General Hospital
Phase: Phase II , Start Date: Dec 20, 2009
Clinical Trials – Sep 23, 2015

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis


BRIEF 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).
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
CONDITION

Chronic Rhinosinusitis
PRIMARY OUTCOME

Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan
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 ≤ 700 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. (See Total Symptom Score under Procedures) - 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 (defined as FEV1 < 80% with - Asthma Control Test <19 for the week prior to entry), recent exacerbation, or 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 a strong - family history of malignancy), or history of recent cocaine use. - 10. Cigarette smoking in the past 3 years.
GENDER: Both
MINIMUM AGE: 18 Years
MAXIMUM AGE: N/A
LOCATION

Massachusetts General Hospital. Boston. Massachusetts. 02114. United States. Recruiting. Ellen J Dutta, MD. Principal Investigator. Daniel L Hamilos, MD. Sub-Investigator. Martin Ostro, MD. Sub-Investigator.
FIRST RECEIVED

February 8, 2010
VERIFICATION DATE

February 2010
LAST CHANGED

February 9, 2010

Loading next page...
/lp/clinical-trials/subcutaneous-omalizumab-for-treatment-of-chronic-rhinosinusitis-with-PWumuw01Oy
Clinical Trials
Clinical Trials
Publisher site
See Article on Publisher Site

Abstract

BRIEF 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). 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 CONDITION Chronic Rhinosinusitis PRIMARY OUTCOME Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan 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 ≤ 700 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. (See Total Symptom Score under Procedures) - 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 (defined as FEV1 < 80% with - Asthma Control Test <19 for the week prior to entry), recent exacerbation, or 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 a strong - family history of malignancy), or history of recent cocaine use. - 10. Cigarette smoking in the past 3 years. GENDER: Both MINIMUM AGE: 18 Years MAXIMUM AGE: N/A LOCATION Massachusetts General Hospital. Boston. Massachusetts. 02114. United States. Recruiting. Ellen J Dutta, MD. Principal Investigator. Daniel L Hamilos, MD. Sub-Investigator. Martin Ostro, MD. Sub-Investigator. FIRST RECEIVED February 8, 2010 VERIFICATION DATE February 2010 LAST CHANGED February 9, 2010

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create folders to
organize your research

Export folders, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off