Sponsor study identifier
interventional
168
1 country
3
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2005
Actual (reported)Study Completion
May 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 19, 2004
Actual (reported)February 20, 2004
Actual (reported)May 2005
Actual (reported)May 2005
Actual (reported)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.
2003 ragweed pollen season
Incidence and severity of adverse events
2003 ragweed pollen season
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).
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.
University of Iowa
Iowa City, Iowa, 52242, United States
Creighton University
Omaha, Nebraska, 68131, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
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.
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.
Thomas Casale, MD
Creighton University
First Submitted
February 19, 2004
First Posted
February 20, 2004
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2005
Actual (reported)Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Number of days with rescue medication (fexofenadine HCl 60 mg) use
2003 ragweed pollen season
Number of rescue medication capsules used
2003 ragweed pollen season
Rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores
2003 ragweed pollen season
Daily morning allergy symptom scores
2003 ragweed pollen season
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).
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
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.
The placebo for rush immunotherapy will contain the diluents and histamine.
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
The placebo for immunotherapy will contain the diluents and histamine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Study Completion
May 2005
Actual (reported)Last Updated
October 18, 2016
Record last verified: 2016-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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