A three-armed prospective randomized double-blind placebo-controlled trial investigating the efficacy of standard care plus 4-5 months of treatment with (a) a boost of inhaled corticosteroid therapy Flovent Diskus (fluticasone) versus (b) Xolair(omalizumab) or (c) placebo Xolair (omalizumab) and placebo Flovent Diskus (fluticasone) in reducing the exacerbations during the fall season.

instance of dataset

2 - Complete set of descriptive data and results, as ascertained by ImmPort.

available with registration

The primary objective of this trial is to compare the efficacy of 4 to 5 months of 3 treatments - Xolair (omalizumab), inhaled corticosteroid (ICS) therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 to 6 weeks prior to the first day of each participant's school year. The secondary objectives are to 1) To compare the efficacy of the 3 treatment strategies in reducing exacerbations and/or the duration or intensity of asthma symptoms associated with viral respiratory infection. 2) To compare the efficacy of the Xolair (omalizumab) vs. placebo in reducing exacerbations in participants taking 1000 mcg of Flovent Diskus (fluticasone) daily. 3) To compare the efficacy of the 3 treatment strategies in improving asthma control (as measured by the CACT or ACT questionnaire) and in reducing asthma severity (as measured by the Composite Asthma Severity Index) during the fall season. 4) To measure the pharmacoeconomic impact of utilizing these treatment strategies. 5) To determine if response to each treatment strategy is associated with specific pre-randomization asthma characteristics: degree of atopy, total IgE level, allergen-specific IgE levels, dust mite sensitivity and/or exposure, cockroach sensitivity and exposure, demographic characteristics, eNO, and viral detection by RT-PCR. 6) To identify risk factors and predictors of exacerbations. 7) To explore the interaction of allergen sensitivity and exposure with viral illnesses as determinants of exacerbations. 8) To determine the safety of each treatment regimen. 9) To measure time of onset of exacerbations between groups.

registration required

Asthma

William Busse

Samuel Arbes

University of Wisconsin-Madison

Rho

principal investigator

Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE)

513

Inner City Asthma Consortium (ICAC)

The primary endpoint is the occurrence of >= 1 asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome.

ICS Therapy: This group uses ICS therapy as a treatment to reduce exacerbations.

Xolair (omalizumab): This group uses Xolair (omalizumab) as a treatment for reducing exacerbations.

Placebo: This group uses a Placebo as a treatment for reducing exacerbations.

Unknown: Unknown

A three-armed prospective randomized double-blind placebo-controlled trial investigating the efficacy of standard care plus 4-5 months of treatment with (a) a boost of inhaled corticosteroid therapy Flovent Diskus (fluticasone) versus (b) Xolair(omalizumab) or (c) placebo Xolair (omalizumab) and placebo Flovent Diskus (fluticasone) in reducing the exacerbations during the fall season.

10.21430/M3HZZOS3Y5

2011-09-29

ImmPort

SCR:012804