Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133042
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2005-08-19
Brief Title:
The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma because of poor adherence will decrease allergic airway inflammation and improve asthma control
Detailed Description:
Patients with moderate to severe allergic asthma who are poorly adherent to inhaled corticosteroids ICS have persistent airway inflammation that results in excessive morbidity and sometimes death Omalizumab OMB an anti-IgE monoclonal antibody decreases the release of mediators from mast cells reduces the frequency of exacerbations and allows a reduction in ICS dose However there are no data on the effects of OMB on airway inflammation Bronchoprovocation with adenosine 5 monophosphate AMP is a robust and sensitive non-invasive measure of allergic airway inflammation but the effect of OMB on this surrogate marker has not been previously reported Based upon the mechanisms of actions of OMB and AMP and the fact that OMB will be administered at 2-4 week intervals in the clinic ie direct observed therapy it is our hypothesis that treatment with this new agent will reduce airway responsiveness to AMP and compensate for poor adherence to ICS
To test this hypothesis we will select 16 patients 6-26 yrs with a total IgE of 30-1300 IUml sensitivity to at least one allergen an FEV1 60 predicted and documented poor adherence to ICS with inadequate asthma control Subjects will be randomized to receive OMB 150-375 mg subcutaneously or placebo every 2-4 weeks for four months each in a double-blind crossover manner with a 3 month washout period between treatments Spirometry will be measured before each injection and at the end of each treatment period The concentration of AMP that will provoke a 20 decrease in FEV1 PC20 FEV1 and a free IgE serum concentration will be measured before and at the end of each treatment period After randomization a 5-day course of oral prednisone will be administered whenever bronchodilator-unresponsive symptoms persist or FEV1 is 60 predicted ANOVA for repeated measures will be used to evaluate differences between treatments in Δ PC20 primary endpoint and Δ FEV1 while the Friedman Statistic will be used to evaluate differences in the number of short courses of prednisone The results of this study will provide new information on the extent to which OMB decreases airway responsiveness to AMP ie allergic airway inflammation and whether this new therapy will fill an unmet need for patients who have inadequately controlled asthma because of poor adherence to inhaled corticosteroids
To test this hypothesis we will select 16 patients 6-26 yrs with a total IgE of 30-1300 IUml sensitivity to at least one allergen an FEV1 60 predicted and documented poor adherence to ICS with inadequate asthma control Subjects will be randomized to receive OMB 150-375 mg subcutaneously or placebo every 2-4 weeks for four months each in a double-blind crossover manner with a 3 month washout period between treatments Spirometry will be measured before each injection and at the end of each treatment period The concentration of AMP that will provoke a 20 decrease in FEV1 PC20 FEV1 and a free IgE serum concentration will be measured before and at the end of each treatment period After randomization a 5-day course of oral prednisone will be administered whenever bronchodilator-unresponsive symptoms persist or FEV1 is 60 predicted ANOVA for repeated measures will be used to evaluate differences between treatments in Δ PC20 primary endpoint and Δ FEV1 while the Friedman Statistic will be used to evaluate differences in the number of short courses of prednisone The results of this study will provide new information on the extent to which OMB decreases airway responsiveness to AMP ie allergic airway inflammation and whether this new therapy will fill an unmet need for patients who have inadequately controlled asthma because of poor adherence to inhaled corticosteroids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None