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Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

Primary Purpose

Hay Fever, Hypersensitivity, Allergy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
omalizumab
Placebo omalizumab
Ragweed rush immunotherapy (RIT)
Placebo rush immunotherapy (RIT)
Ragweed immunotherapy (IT)
Placebo immunotherapy (IT)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hay Fever focused on measuring Ragweed, Immunotherapy, Rush Immunotherapy, RIT, Hayfever, Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Able to comprehend and grant a witnessed, written informed consent prior to any study procedures. Female participants of child bearing age must have a negative urine pregnancy test at Screening Visit and subsequent visits. In addition, female participants must be using a medically acceptable form of birth control. History of seasonal allergic rhinitis for at least 2 years with symptoms during the ragweed pollen season requiring pharmacotherapy. A positive skin test by prick method to ragweed pollen at the Screening Visit. A positive skin prick test will be defined as a ragweed pollen-induced wheal greater than 3 mm larger in diameter than diluent control (measurements will be made 15-20 minutes after application). Must be capable of faithfully completing the diary and of attending regularly scheduled study visits. Must intend to remain in the ragweed pollen area during the entire ragweed season. Willing to avoid prohibited medications for the periods indicated in the protocol. Participants must meet pretrial eligibility requirements for trial enrollment (acceptable medical history, physical examination results, normal electrocardiogram and acceptable laboratory test results). Participants must have a baseline serum Immunoglobulin E (IgE) level greater than 10 and less than 700 IU/mL. Exclusion Criteria weigh less than 30 kg or more than 120 kg. pregnant or lactating. history of severe anaphylactoid (non-IgE mediated) or anaphylactic reactions). history of immunotherapy within the past 10 years, if received one full year of immunotherapy, or within the past 5 years if received less than one year of immunotherapy. known hypersensitivity to trial rescue medication (fexofenadine HCl). taking beta-adrenergic antagonists in any form. taking allergic ophthalmologic medication. clinically significant perennial rhinitis that would interfere in assessment of ragweed-induced seasonal allergic rhinitis symptoms. Presence of a severely deviated nasal septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction. History of an upper respiratory or sinus infection requiring treatment with an antibiotic within 2 weeks prior to Screening Visit. Documented evidence of acute or significant chronic sinusitis, as determined by the Investigator. Asthma (either history of, abnormal spirometry, [forced expiratory volume in 1 second (FEV1) less than 80% predicted] or use of asthma medications). Chronic or intermittent use of inhaled, oral, intra-muscular, or intra-venous corticosteroids; or chronic or intermittent use of topical corticosteroids within 4 weeks of Visit Screening Visit. Chronic use of medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication. Rhinitis medicamentosa. History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal or other significant medical condition including, autoimmune or collagen vascular disorders, aside from organ-specific autoimmune disease limited to the thyroid that in the Investigator's opinion could interfere with the study or require medical treatment that would interfere with the study. History of cancer other than basal cell carcinoma of the skin. History within the past year of excessive alcohol intake or drug addiction. Current smokers, greater than 10 pack year history, or participants who quit smoking less than one year prior to Screening. Use of any prohibited concomitant medications during the washout period (i.e., before screening) and throughout the study period. Participants currently undergoing immunotherapy. Participants with clinically significant abnormality on 12-lead Electrocardiogram (ECG) on screening visit. Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days. Participants with a history of noncompliance to medical regimens and participants who are considered potentially unreliable. Previous treatment with a monoclonal antibody for any reason including anti-IgE in any form (e.g., omalizumab). Participants with known hypersensitivity to trial drug ingredients (i.e., sucrose, histidine, polysorbate 20) or related drugs (i.e., monoclonal antibody; polyclonal gamma-globulin).

Sites / Locations

  • University of Iowa
  • Creighton University
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT

Omalizumab pre-treatment, omalizumab

Ragweed RIT, ragweed IT

Placebo

Arm Description

Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT).

Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT).

Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT).

Participants are pre-treated with placebo omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus placebo immunotherapy (IT).

Outcomes

Primary Outcome Measures

Average daily allergy severity score
The average daily allergy severity score will be calculated from participants' 5 symptom scores (sneezing; rhinorrhea/runny nose; itchy nose, throat, and palate; itchy, watery eyes; and nasal congestion/stuffiness) during the ragweed pollen season. Symptom scores are recorded twice daily (AM and PM). The sum of the individual symptom scores will be averaged over AM and PM to give a daily score. Each daily score will then be averaged to obtain one measure of the average daily allergy severity score for each participant. The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.

Secondary Outcome Measures

Incidence and severity of adverse events
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Number of days with rescue medication (fexofenadine HCl 60 mg) use
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Number of rescue medication capsules used
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Daily morning allergy symptom scores
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Daily nighttime allergy symptom scores during the 2003 ragweed season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Individual allergy symptom scores during the 2003 ragweed season
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.

Full Information

First Posted
February 19, 2004
Last Updated
October 14, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)
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1. Study Identification

Unique Protocol Identification Number
NCT00078195
Brief Title
Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
Official Title
Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody (ITN019AD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.
Detailed Description
Allergic rhinitis affects 20 to 40 million Americans annually. Allergy symptoms, which can range from mild to seriously debilitating, may affect quality of life. Left untreated, allergic rhinitis can exacerbate or trigger more serious conditions, such as asthma and sinus inflammation. Individuals with allergies react to harmless particles such as dust or pollen. Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response. The immune response results in harmful inflammation of healthy tissues. In ragweed allergy, inflammation occurs in the airways and causes familiar allergy symptoms like sneezing, coughing, and general discomfort. Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies. The blocking effect of omalizumab is temporary, but giving the drug to people before their regular allergy shots may make the shots more effective. Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots (given over 12 weeks). The participants will return for follow-up for up to one year, and they may have as many as 27 study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hay Fever, Hypersensitivity, Allergy, Rhinitis
Keywords
Ragweed, Immunotherapy, Rush Immunotherapy, RIT, Hayfever, Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
168 (false)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT
Arm Type
Experimental
Arm Description
Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT).
Arm Title
Omalizumab pre-treatment, omalizumab
Arm Type
Experimental
Arm Description
Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT).
Arm Title
Ragweed RIT, ragweed IT
Arm Type
Active Comparator
Arm Description
Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants are pre-treated with placebo omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus placebo immunotherapy (IT).
Intervention Type
Biological
Intervention Name(s)
omalizumab
Other Intervention Name(s)
Xolair™, anti-Immunoglobulin E (IgE)
Intervention Description
A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
Intervention Type
Biological
Intervention Name(s)
Placebo omalizumab
Intervention Description
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
Intervention Type
Biological
Intervention Name(s)
Ragweed rush immunotherapy (RIT)
Intervention Description
RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
Intervention Type
Biological
Intervention Name(s)
Placebo rush immunotherapy (RIT)
Intervention Description
The placebo for rush immunotherapy will contain the diluents and histamine.
Intervention Type
Biological
Intervention Name(s)
Ragweed immunotherapy (IT)
Intervention Description
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Placebo immunotherapy (IT)
Intervention Description
The placebo for immunotherapy will contain the diluents and histamine.
Primary Outcome Measure Information:
Title
Average daily allergy severity score
Description
The average daily allergy severity score will be calculated from participants' 5 symptom scores (sneezing; rhinorrhea/runny nose; itchy nose, throat, and palate; itchy, watery eyes; and nasal congestion/stuffiness) during the ragweed pollen season. Symptom scores are recorded twice daily (AM and PM). The sum of the individual symptom scores will be averaged over AM and PM to give a daily score. Each daily score will then be averaged to obtain one measure of the average daily allergy severity score for each participant. The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Number of days with rescue medication (fexofenadine HCl 60 mg) use
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Number of rescue medication capsules used
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Daily morning allergy symptom scores
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Daily nighttime allergy symptom scores during the 2003 ragweed season
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season
Title
Individual allergy symptom scores during the 2003 ragweed season
Description
The ragweed pollen season begins when the ragweed pollen counts rise to 10 ragweed pollen grains/m3/24 hours or above on two consecutive recorded days, and the ragweed pollen season ends when the ragweed pollen counts fall below 10 ragweed pollen grains/m3/24 hours on two consecutive recorded days. The ragweed pollen season is from approximately August 15, 2003 to October 1, 2003, but varies among the sites.
Time Frame
2003 ragweed pollen season

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Able to comprehend and grant a witnessed, written informed consent prior to any study procedures. Female participants of child bearing age must have a negative urine pregnancy test at Screening Visit and subsequent visits. In addition, female participants must be using a medically acceptable form of birth control. History of seasonal allergic rhinitis for at least 2 years with symptoms during the ragweed pollen season requiring pharmacotherapy. A positive skin test by prick method to ragweed pollen at the Screening Visit. A positive skin prick test will be defined as a ragweed pollen-induced wheal greater than 3 mm larger in diameter than diluent control (measurements will be made 15-20 minutes after application). Must be capable of faithfully completing the diary and of attending regularly scheduled study visits. Must intend to remain in the ragweed pollen area during the entire ragweed season. Willing to avoid prohibited medications for the periods indicated in the protocol. Participants must meet pretrial eligibility requirements for trial enrollment (acceptable medical history, physical examination results, normal electrocardiogram and acceptable laboratory test results). Participants must have a baseline serum Immunoglobulin E (IgE) level greater than 10 and less than 700 IU/mL. Exclusion Criteria weigh less than 30 kg or more than 120 kg. pregnant or lactating. history of severe anaphylactoid (non-IgE mediated) or anaphylactic reactions). history of immunotherapy within the past 10 years, if received one full year of immunotherapy, or within the past 5 years if received less than one year of immunotherapy. known hypersensitivity to trial rescue medication (fexofenadine HCl). taking beta-adrenergic antagonists in any form. taking allergic ophthalmologic medication. clinically significant perennial rhinitis that would interfere in assessment of ragweed-induced seasonal allergic rhinitis symptoms. Presence of a severely deviated nasal septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction. History of an upper respiratory or sinus infection requiring treatment with an antibiotic within 2 weeks prior to Screening Visit. Documented evidence of acute or significant chronic sinusitis, as determined by the Investigator. Asthma (either history of, abnormal spirometry, [forced expiratory volume in 1 second (FEV1) less than 80% predicted] or use of asthma medications). Chronic or intermittent use of inhaled, oral, intra-muscular, or intra-venous corticosteroids; or chronic or intermittent use of topical corticosteroids within 4 weeks of Visit Screening Visit. Chronic use of medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication. Rhinitis medicamentosa. History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal or other significant medical condition including, autoimmune or collagen vascular disorders, aside from organ-specific autoimmune disease limited to the thyroid that in the Investigator's opinion could interfere with the study or require medical treatment that would interfere with the study. History of cancer other than basal cell carcinoma of the skin. History within the past year of excessive alcohol intake or drug addiction. Current smokers, greater than 10 pack year history, or participants who quit smoking less than one year prior to Screening. Use of any prohibited concomitant medications during the washout period (i.e., before screening) and throughout the study period. Participants currently undergoing immunotherapy. Participants with clinically significant abnormality on 12-lead Electrocardiogram (ECG) on screening visit. Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days. Participants with a history of noncompliance to medical regimens and participants who are considered potentially unreliable. Previous treatment with a monoclonal antibody for any reason including anti-IgE in any form (e.g., omalizumab). Participants with known hypersensitivity to trial drug ingredients (i.e., sucrose, histidine, polysorbate 20) or related drugs (i.e., monoclonal antibody; polyclonal gamma-globulin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Casale, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research data sharing portal.
Citations:
PubMed Identifier
14619332
Citation
Nayak A, Casale T, Miller SD, Condemi J, McAlary M, Fowler-Taylor A, Della Cioppa G, Gupta N. Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2003 Sep-Oct;24(5):323-9.
Results Reference
result
PubMed Identifier
16387596
Citation
Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, Mokhtarani M, Seyfert-Margolis V, Asare A, Bateman K, Deniz Y; Immune Tolerance Network Group. Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2006 Jan;117(1):134-40. doi: 10.1016/j.jaci.2005.09.036. Epub 2005 Dec 2.
Results Reference
result
PubMed Identifier
17631952
Citation
Klunker S, Saggar LR, Seyfert-Margolis V, Asare AL, Casale TB, Durham SR, Francis JN; Immune Tolerance Network Group. Combination treatment with omalizumab and rush immunotherapy for ragweed-induced allergic rhinitis: Inhibition of IgE-facilitated allergen binding. J Allergy Clin Immunol. 2007 Sep;120(3):688-95. doi: 10.1016/j.jaci.2007.05.034. Epub 2007 Jul 12.
Results Reference
result
Links:
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)
URL
http://www.immunetolerance.org
Description
Immune Tolerance Network (ITN)
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY1
Available IPD/Information Identifier
SDY1
Available IPD/Information Comments
ImmPort study identifier is SDY1
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY1
Available IPD/Information Identifier
SDY1
Available IPD/Information Comments
ImmPort study identifier is SDY1
Available IPD/Information Type
Study design, -summary, -files, -interventions, participant schedule of events, -demographics, et al.
Available IPD/Information URL
http://www.itntrialshare.org/project/Studies/ITN019ADPUBLIC/Study%20Data/begin.view?
Available IPD/Information Identifier
SDY1
Available IPD/Information Comments
ImmPort study identifier is SDY1
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.itntrialshare.org/project/Studies/ITN019ADPUBLIC/Study%20Data/begin.view?
Available IPD/Information Identifier
CASALE ITN019AD
Available IPD/Information Comments
TrialShare study identifier is CASALE ITN019AD
Available IPD/Information Type
Study protocol synopsis; -schedule of assessments; -data and reports; -specimens availability et al.
Available IPD/Information URL
http://www.itntrialshare.org/project/Studies/ITN019ADPUBLIC/Study%20Data/begin.view?
Available IPD/Information Identifier
CASALE ITN019AD
Available IPD/Information Comments
TrialShare study identifier is CASALE ITN019AD

Learn more about this trial

Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

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