Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02023151
Eligibility Criteria:
Inclusion Criteria:
* Patients with moderate-to-severe asthma; male and females aged 18-75 who are symptomatic despite treatment with inhaled corticosteroids if they also had an asthma duration \> 1 year.
* Positive blood testing to at least one common allergen (including must mite, D. F. and D. P., cockroach, dog or cat)
* Serum IgE within the bounds of the dosing table (\>30 IU/ml to \< 700 IU/ml)
* Reversibility of \> 12% within 30 minutes after administration of albuterol or history of reversibility in past or history of positive methacholine in past
* Baseline Forced expiratory volume (FEV1) of \> 0% and \< 80% of predicted
* Treatment with 400 to 800 ug day of beclomethasone dipropionate or its equivalent.
* Patients must be willing to give written informed consent and be able to adhere to dose and visit schedules and meet trial requirements.
* Patients will be excluded if they have prior sensitivity to omalizumab, and acute respiratory tract infection prior to or during the run-in period, or a need for regular B-agonist use.
Exclusion Criteria:
* Treatment with an investigational agent within 30 days of screening
* Previously treated with omalizumab within a year prior to screening
* Treatment 1 month prior to screening with: hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G, and plasmapheresis
* Clinically relevant laboratory anomalies at screening including individuals with reduced hematocrit (\<32%), White Blood Cell (WBC) count (2400/microliter), platelet count (\< 75000/microliter), and increased creatinine (\> 141.4 micromolar/L), or aminotransferase (AST) (\>100 IU/L).
* Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy, or bleeding disorder.
* History of any medical condition that is unstable
* Inability to comply with study and follow-up procedures
* Patients may not take systemic corticosteroids within 2 weeks prior to screening\\
* Women of childbearing potential who are pregnant or nursing mothers, or who are of childbearing potential (post-menarche) and are not practicing an acceptable form of contraception ( as determined by the site investigator)
* Individuals with body weight less than 30 kg or greater than 150 kg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02023151
Study Brief:
Protocol Section:
NCT02023151