clinical Trials - asthma

Moderate to severe asthma inadequately treated with Xolair®:

This clinical trial is designed for patients with moderate to severe persistent asthma, which has been inadequately controlled with Advair®. This study looks at adding Xolair® to ongoing treatment with Advair®. For more information about this trial, click here. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Signed Informed Consent Form and an informed assent if applicable.
Be between the ages of 12 to 75 years.
Have had a history of moderate to severe asthma for at least one year prior to screening.
Have had treatment with Advair 500/50 BID for at least 8 weeks prior to screening.
Have a baseline FEV1 > 40% and < 80% predicted.
Have inadequately controlled asthmas as defined below. In the 4 weeks prior to screening, the subject must exhibit inadequate asthma control.
Have inadequately controlled asthma for 2 consecutive weeks out of up to 4 weeks prior to randomization.
Have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with fluticasone 500µ BID or equivalent dose ICS.
Have less than 10 pack-years smoking history.
Have a positive skin-prick test for or a positive, in vitro response to one relevant perennial aeroallergen within the past 12 months or at screening.
Subjects must meet the study drug-dosing table eligibility criteria.
Female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study.
For the collection of additional blood samples for future research, provide signed consent.

The following criteria would exclude a patient from this trial:

Have had an asthma exacerbation requiring intubation within 12 prior to screening.
Have active lung disease other than asthma.
Have asthma requiring systemic corticosteroids within 30 days prior to screening.
Require chronic immunosuppressive therapy including systemic corticosteroids, cyclosporine, methotrexate, etc.
Have significant medical illness other than asthma.
Have taken methotrexate, gold salts, cyclosporine or troleandomycin within 3 months prior to screening.
Have taken other investigational drugs within 30 days prior to screening.
Have been previously treated with Xolair.
Are unable or unwilling to comply with study procedures and visits.
Have a history of drug or alcohol abuse.
Have elevated serum IgE levels for reasons other that allergy.
Are pregnant or lactating.