clinical Trials - asthma

Severe asthma difficult to treat with steroids:

This clinical trial is designed for patients with asthma, which has been difficult to treat with inhaled steroids. This study looks at two different doses of Xolair® as compared to placebo in patients who have good lung capacity, are on inhaled steroids, yet continue to have problems with their asthma. 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:

Have signed an Informed Consent Form.
Be between age 12 and 75 years old at the time of screening.
Have a documented diagnosis of asthma defined with a > 12% reversibility of lung function by spirometry in the past 12 months, or at screening.
Have screening FEV1 > 80% predicted normal value.
Have a positive skin-prick test to one relevant perennial aeroallergen such as cat or house dust mite documented within the previous year, or at screening.
Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder inhaler (DPI) > 200 µg/day or equivalent ex-valve dose during the 12 weeks prior to screening visit.
Have had at least one asthma exacerbation requiring treatment with at least one course of oral corticosteroids in the 12 months prior to screening despite being on ICS.
During the 4-week run-in period prior to randomization, demonstrate evidence of inadequate asthma symptom control despite ICS with or without controller asthma medications.

The following criteria would exclude a patient from this trial:

Have received chronic systemic or oral corticosteroids within 3 months or have received a burst of oral corticosteroids within the last 2 weeks prior to screening.
Are pregnant or lactating.
Have a known hypersensitivity to any ingredients of Xolair, including excipients.
Have a lifetime history of smoking > 10-pack years.
Have active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, COPD.
Have a history of upper respiratory infection or lower respiratory infection within the 30 days prior to randomization.
Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma.
Have taken immunosuppressants or other investigational drugs within the 30 days prior to screening.
Have a significant medical illness other than asthma.