Hay FeverPhase 2NCT00078195
Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
A Phase 2 study testing omalizumab, Ragweed rush immunotherapy (RIT) and Ragweed immunotherapy (IT) in people with Hay Fever and Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hay Fever, Hypersensitivity, Allergy
- What is being tested?
- omalizumab, Ragweed rush immunotherapy (RIT) and Ragweed immunotherapy (IT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2003to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53705
Creighton University
Omaha, Nebraska, 68131
About this study
Official title: Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody (ITN019AD)
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.
Read the 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.
- Conditions
- Hay Fever, Hypersensitivity, Allergy, Rhinitis
- Being tested
- omalizumab, Placebo omalizumab, Ragweed rush immunotherapy (RIT), Placebo rush immunotherapy (RIT), Ragweed immunotherapy (IT)
- Keywords
- Ragweed, Immunotherapy, Rush Immunotherapy, RIT, Hayfever, Seasonal Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabBiological
Also called Xolair™, anti-Immunoglobulin E (IgE)
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.
Placebo omalizumabBiological
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
Ragweed rush immunotherapy (RIT)Biological
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.
Placebo rush immunotherapy (RIT)Biological
The placebo for rush immunotherapy will contain the diluents and histamine.
Ragweed immunotherapy (IT)Biological
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
Placebo immunotherapy (IT)Biological
The placebo for immunotherapy will contain the diluents and histamine.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT | Experimental | Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT). Receives: Biological: omalizumab; Biological: Ragweed rush immunotherapy (RIT); Biological: Ragweed immunotherapy (IT) |
| Omalizumab pre-treatment, omalizumab | Experimental | Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT). Receives: Biological: omalizumab; Biological: Placebo rush immunotherapy (RIT); Biological: Placebo immunotherapy (IT) |
| Ragweed RIT, ragweed IT | Active comparator | Participants are pre-treated with placebo omalizumab followed by ragweed rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus ragweed immunotherapy (IT). Receives: Biological: Placebo omalizumab; Biological: Ragweed rush immunotherapy (RIT); Biological: Ragweed immunotherapy (IT) |
| Placebo | Placebo comparator | Participants are pre-treated with placebo omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with placebo omalizumab plus placebo immunotherapy (IT). Receives: Biological: Placebo omalizumab; Biological: Placebo rush immunotherapy (RIT); Biological: Placebo immunotherapy (IT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2003 ragweed pollen season
Secondary outcomes (7)
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
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.
Measured: 2003 ragweed pollen season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startApr 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hay FeverStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 168 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Thomas Casale, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078195
- Sponsor's protocol ID
- DAIT ITN019AD
- Status last verified
- Oct 2016
- First submitted
- 19 Feb 2004
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 14619332Casale 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.
PubMed 16387596Klunker 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.
PubMed 17631952
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody (ITN019AD)
- ClinicalTrials.gov ID
- NCT00078195
- Acronym / sponsor ID
- DAIT ITN019AD
- Conditions
- Hay Fever, Hypersensitivity, Allergy, Rhinitis
- Keywords
- Ragweed, Immunotherapy, Rush Immunotherapy, RIT, Hayfever, Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- Apr 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT | Experimental | Biological: omalizumab, Biological: Ragweed rush immunotherapy (RIT), Biological: Ragweed immunotherapy (IT)Participants are pre-treated with omalizumab followed by ragweed rush immunotherapy (RIT) followed by dual therapy with omalizumab plus ragweed immunotherapy (IT). |
| Omalizumab pre-treatment, omalizumab | Experimental | Biological: omalizumab, Biological: Placebo rush immunotherapy (RIT), Biological: Placebo immunotherapy (IT)Participants are pre-treated with omalizumab followed by placebo rush immunotherapy (RIT), followed by dual therapy with Omalizumab plus placebo immunotherapy (IT). |
| Ragweed RIT, ragweed IT | Active comparator | Biological: Placebo omalizumab, Biological: Ragweed rush immunotherapy (RIT), Biological: Ragweed 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). |
| Placebo | Placebo comparator | Biological: Placebo omalizumab, Biological: Placebo rush immunotherapy (RIT), Biological: Placebo 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumabAlso: Xolair™, anti-Immunoglobulin E (IgE)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. | Biological | Omalizumab pre-treatment, omalizumab, Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT |
| Placebo omalizumabThe placebo for omalizumab will contain the excipients and diluents of the omalizumab. | Biological | Placebo, Ragweed RIT, ragweed IT |
| Ragweed rush immunotherapy (RIT)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. | Biological | Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT, Ragweed RIT, ragweed IT |
| Placebo rush immunotherapy (RIT)The placebo for rush immunotherapy will contain the diluents and histamine. | Biological | Omalizumab pre-treatment, omalizumab, Placebo |
| Ragweed immunotherapy (IT)Participants will receive weekly maintenance IT dosing for a total of 12 weeks. | Biological | Omalizumab pre-treatment, ragweed RIT, omalizumab + ragweed IT, Ragweed RIT, ragweed IT |
| Placebo immunotherapy (IT)The placebo for immunotherapy will contain the diluents and histamine. | Biological | Omalizumab pre-treatment, omalizumab, Placebo |
Primary outcome
Average daily allergy severity score
Time frame: 2003 ragweed pollen season
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.
7 secondary outcomes
Incidence and severity of adverse events
Time frame: 2003 ragweed pollen season
Number of days with rescue medication (fexofenadine HCl 60 mg) use
Time frame: 2003 ragweed pollen season
Number of rescue medication capsules used
Time frame: 2003 ragweed pollen season
Rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores
Time frame: 2003 ragweed pollen season
Daily morning allergy symptom scores
Time frame: 2003 ragweed pollen season
Daily nighttime allergy symptom scores during the 2003 ragweed season
Time frame: 2003 ragweed pollen season
Individual allergy symptom scores during the 2003 ragweed season
Time frame: 2003 ragweed pollen season
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Results publication: PubMed 14619332Nayak 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 publication: PubMed 16387596Casale 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 publication: PubMed 17631952Klunker 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Casale, MD principal investigator
Creighton University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omalizumab, Ragweed rush immunotherapy (RIT) and Ragweed immunotherapy (IT) in people with Hay Fever and Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily allergy severity score (time frame: 2003 ragweed pollen season). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078195, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.