Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherap… (NCT00267202) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
United States275 participantsStarted 2005-12
Plain-language summary
This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent allergic asthma.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients were eligible for inclusion if they met all of the following criteria:
Informed Consent
* Patients who were informed of the study procedures and medications and provided their written informed consent
Demographics
* Male or female
* Any race
* Ages 18 - 55 years
* Body weight \>=20 kg and \<=150 kg
* Total serum IgE concentration \>=30 and \<=700 IU/mL at Visit 0
Disease Definitions/Medications
* History of at least moderate persistent allergic asthma (consistent with Global Initiative for Asthma \[GINA\] guidelines of \>=1 year in duration
* On a stable asthma treatment regimen including inhaled corticosteroids for the preceding 4 weeks
* An FEV1 while withholding short-acting beta-agonists for at least 6 hours and long-acting beta-agonists for at least 12 hours, of \>=75% of the predicted value at Visit 0
* Evidence of reversible airway obstruction, as defined by an increase in FEV1 of \>=12% between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit 0 or within the preceding year
* Documented sensitivity to perennial aeroallergens, as evidenced by a positive skin test (wheal \>=5mm greater than saline control) to at least 1 of 3 perennial aeroallergens (house dust mite, cat, or dog) at Visit 0 or within the preceding year
* Average PEFR variability \<=20% (calculated as \[(PM PEF - AM PEF)/(PM PEF + AM PEF)/2 x 100) during the 2-week screening period…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)