Xolair clinical trial results

This is why they are so important to do—and why so many are done. In this group, patients received inhaled corticosteroid treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. Placebos can take many forms, such as a pill, an injection, or even a procedure. You may also report side effects to Genentech at or Novartis Pharmaceuticals Corporation at The information contained in this section of the site is intended for U.

Click "OK" if you are a healthcare professional. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. Results of allergic asthma studies in adults and adolescents Results of another allergic asthma study in adults and adolescents Results of an allergic asthma study in children yrs.

In clinical studies, adding XOLAIR has been shown to: Help reduce attacks and symptoms in appropriate allergic asthma patients 12 years of age and older. Help reduce attacks in appropriate patients 6 to less than 12 years old. Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have a latex allergy or any other allergies such as food allergy or seasonal allergies.

The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex have sudden breathing problems bronchospasm have ever had a severe allergic reaction called anaphylaxis have or have had a parasitic infection have or have had cancer are pregnant or plan to become pregnant. Asthma symptoms in Studies 1 and 2 were defined as: Daytime symptoms: chest tightness, shortness of breath, coughing, and wheezing Nighttime symptoms: awakenings and breathing problems requiring rescue medication How the studies were done: The studies had patients 12 to 76 years old with moderate to severe, persistent allergic asthma uncontrolled on inhaled corticosteroids.

During the first 16 weeks of each study, both groups of patients took their prescribed dose of inhaled corticosteroid treatment. Then, over the next 12 weeks , their inhaled corticosteroid dose was slowly reduced. How did we define asthma attack in these studies?

Study 1 Results. Study 2 Results. In people with asthma, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency. Do not decrease or stop taking any of your other asthma medicine unless your healthcare providers tell you to. If your asthma symptoms do not improve or get worse, call your healthcare provider. Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Results First Posted : October 13, Last Update Posted : February 9, Study Description. Drug Information available for: Omalizumab.

FDA Resources. Arms and Interventions. Omalizumab Xolair was administered by subcutaneous SC injection every 2 or 4 weeks. Placebo was administered by subcutaneous SC injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab.

Outcome Measures. Primary Outcome Measures : Rate of Asthma Exacerbations Over the 48 Week Treatment Period [ Time Frame: 48 weeks ] A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone or a similar dose of another systemic corticosteroid.

The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group. Secondary Outcome Measures : Change From Baseline in Total Asthma Symptom Scores [ Time Frame: Baseline and Week 48 ] Change from baseline to week 48 in Total Asthma Symptom Score TASS , which included a nocturnal asthma score 0 to 4 scale , morning asthma symptoms yes or no , and a daytime asthma symptom score 0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough.

Score achieved by week 48 minus baseline. Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline. Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire AQLQ[S] score.

Overall outcome achieved by mean visit minus baseline. This outcome is represented in the adverse event section of the database. Eligibility Criteria. Exclusion Criteria: Have had an asthma exacerbation requiring intubation within 12 months prior to screening Have active lung disease other than asthma Have had an asthma exacerbation requiring treatment with the addition of systemic oral or intravenous corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.

Have significant medical illness other than asthma Have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening Have taken other investigational drugs within 30 days prior to screening Have been treated with Xolair within the 12 months prior to screening Have a history of drug or alcohol abuse that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study Have elevated serum IgE levels for reasons other than allergy Are pregnant or lactating.

Results First Posted : November 4, Last Update Posted : November 4, Study Description. The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines H1AH therapy in adult patients suffering from Chronic Spontaneous Urticaria CSU who remained symptomatic despite H1AH therapy. Detailed Description:.

Drug Information available for: Omalizumab. FDA Resources. Arms and Interventions. Outcome Measures. The possible range of the weekly UAS7 score is 0 to A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. A patient with missing data at Week 12 was imputed as a responder if the patient was a responder at Week 10 and Week 11, otherwise as a non-responder.

Dermatology life quality index DLQI is a item dermatology- specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment.

Each domain had 4 response categories ranging from 0 not at all to 3 very much. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. Eligibility Criteria. Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day screening visit Patients must have documented current use on the day of the initial screening visit Main Exclusion Criteria Clearly defined underlying etiology for chronic urticarias other than CSU main manifestation being physical urticaria Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

More Information. Publications automatically indexed to this study by ClinicalTrials. National Library of Medicine U.

National Institutes of Health U.