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.
", "objectives" : "Primary Objective:
To examine whether omalizumab given prior to RIT followed by 12 weeks of dual omalizumab and IT is more effective than RIT followed by IT alone in preventing the symptoms of ragweed-induced SAR.
Secondary Objective:
To examine whether omalizumab given prior to RIT followed by 12 weeks of dual omalizumab and IT is safe and more effective than omalizumab alone or placebo in preventing the symptoms of ragweed-induced SAR; to assess the immunologic mechanisms associated with the therapies; and to assess whether clinical tolerance has been achieved after discontinuation of the therapies.
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.
", "endpoints" : "Primary Objective:
To examine whether omalizumab given prior to RIT followed by 12 weeks of dual omalizumab and
Primary Endpoint:
The primary endpoint will be the average daily allergy severity score, which will be calculated from 5 symptom scores of participants
Symptom scores are recorded twice daily (AM and PM).
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.
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.
Secondary Endpoint:
Secondary Objective:
To examine whether omalizumab given prior to RIT followed by 12 weeks of dual omalizumab and IT is safe and more effective than omalizumab alone or placebo in preventing the symptoms of ragweed-induced SAR; to assess the immunologic mechanisms associated with the therapies; and to assess whether clinical tolerance has been achieved after discontinuation of the therapies.
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.
", "genderIncluded" : null, "sexIncluded" : "Female, Male", "subjectsNumber" : 159, "downloadPackages" : null, "contractGrant" : "Immune Tolerance Network - Casale", "program" : "ITN: Collaborative Network for Clinical Research on Immune Tolerance Network", "dataCompleteness" : "2 - Complete set of descriptive data and results, as ascertained by ImmPort.", "hypothesis" : "Omalizumab given prior to RIT followed by 12 weeks of dual omalizumab and IT may be more effective than RIT followed by IT alone in preventing the symptoms of ragweed-induced SAR.", "sharedStudy" : null, "interventionAgent" : "Omilazumab", "initialDataReleaseDate" : "2010-10-01", "initialDataReleaseVersion" : "DR1", "latestDataReleaseDate" : "2025-10-30", "latestDataReleaseVersion" : "DR58", "studyLinks" : [ { "studyLinkId" : 1, "name" : "Clinicaltrials.gov", "type" : "website", "value" : "http://clinicaltrials.gov/ct2/show/NCT00078195" }, { "studyLinkId" : 2, "name" : "ImmuneTolerance.org", "type" : "website", "value" : "http://www.immunetolerance.org/studies/efficacy-and-safety-evaluation-allergen-immunotherapy-co-administered-with-omalizumab-anti-i" } ], "studyPubmeds" : [ { "id" : { "studyAccession" : "SDY1", "pubmedId" : "16387596" }, "authors" : "Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, Mokhtarani M, Seyfert-Margolis V, Asare A, Bateman K, Deniz Y", "doi" : "10.1016/j.jaci.2005.09.036", "issue" : "117(1)", "journal" : "The Journal of allergy and clinical immunology", "month" : "Jan", "pages" : "134-40", "title" : "Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis.", "year" : "2006" }, { "id" : { "studyAccession" : "SDY1", "pubmedId" : "17631952" }, "authors" : "Klunker S, Saggar LR, Seyfert-Margolis V, Asare AL, Casale TB, Durham SR, Francis JN", "doi" : "10.1016/j.jaci.2007.05.034", "issue" : "120(3)", "journal" : "The Journal of allergy and clinical immunology", "month" : "Sep", "pages" : "688-95", "title" : "Combination treatment with omalizumab and rush immunotherapy for ragweed-induced allergic rhinitis: Inhibition of IgE-facilitated allergen binding.", "year" : "2006" } ], "studyPersonnel" : [ { "personAccession" : "PSN1", "roleInStudy" : "Principal Investigator", "siteName" : "Creighton University", "email" : "tbcasale@creighton.edu", "firstName" : "Thomas", "honorific" : "Dr.", "lastName" : "Casale", "organization" : "Creighton University School of Medicine", "suffixes" : "MD", "titleInStudy" : "Principal Investigator", "workspaceId" : 990 } ] }