Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162773
Status:
TERMINATED
Last Update Posted:
2017-08-28
First Post:
2005-09-08
Brief Title:
Effect of Anti-IgE in Non-Allergic Asthma
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Effect of Anti-IgE in Non-Allergic Asthma
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out if omalizumab is effective in treating non-allergic asthma The US Food and Drug Administration has approved the use of omalizumab to treat moderate to severe allergic asthma
Detailed Description:
Asthma is a chronic inflammatory disease of the lower airways The inflammatory process is associated with changes in airway hyperresponsiveness irritability and airflow limitations caused by bronchoconstriction edema and mucous plugging Mast cells basophils eosinophils activated T-lymphocytes macrophages neutrophils and airway epithelial cells all play a role in this inflammatory process by releasing mediators directly responsible for local inflammation and by releasing mediators that encourage a further influx of inflammatory cells Expert Panel Report 2 1997 These cells and their products eventually produce a state of chronic allergic inflammation leading to increased vascular leakage mucous secretion smooth muscle hyperresponsiveness and nerve activation Clinically this process is characterized by intermittent shortness of breath wheezing coughing and chest tightness
Although most asthmatics are atopic allergic non-atopic asthmatics exist and can develop equally severe disease Non-allergic asthmatics have a trend towards higher than normal levels of the allergic antibody IgE though obviously they lack skin test specificity When examining skin test reactivity and serum IgE as independent variables for asthma risk there was a stronger association with serum IgE elevation than skin test reactivity In fact serum IgE tended to be high in asthmatics regardless of skin test reactivity
Omalizumab Xolair is a recombinant humanized monoclonal antibody that binds specifically to the FceRI binding site on human IgE The binding of omalizumab inhibits the ability of IgE to bind to basophils or mast cells
Omalizumab recently received FDA approval for the treatment of moderate to severe persistent allergic asthma in pediatric 12 years of age and above and adult patients The addition of omalizumab to standard asthma therapies has been found to reduce asthma exacerbations and decrease both inhaled corticosteroid dose and rescue medication use Busse 2001 In a phase III double blinded placebo controlled trial involving 525 severe allergic asthmatics omalizumab treated patients had fewer exacerbations during both a steroid stable phase and steroid reduction phase than did placebo controls Busse 2001 The median reduction in steroid dose during reduction phase was 75 and 50 in the omalizumab and placebo groups respectively In a similarly designed steroid reduction study involving 6 to 12 year-old moderate to severe allergic asthmatics steroid reduction was possible in 100 of treated patient verses 667 of placebo treated patients Milgrom 2001 Other steroid reduction studies have had similar results Buhl 2002 Soler 2001 Omalizumab has also been shown to improve quality of life in allergic asthmatics as measured by the Asthma Quality of Life Questionnaire AQLQ In adults AQLQ demonstrated greater improvement at 16 28 and 52 weeks in omalizumab treated patients than in placebo treated Finn 2003 Similarly in pediatric populations AQLQ improvement reached statistical significance in omalizumab treated patients Lemanske 2002
Omalizumab has shown itself to be a promising new therapy for the treatment of moderate to severe allergic asthma It is currently not indicated for patients with non-allergic asthma The objective of this study will be to define the effects of omalizumab on cell surface FceRI expression and serum IgE of non-allergic asthmatics
Although most asthmatics are atopic allergic non-atopic asthmatics exist and can develop equally severe disease Non-allergic asthmatics have a trend towards higher than normal levels of the allergic antibody IgE though obviously they lack skin test specificity When examining skin test reactivity and serum IgE as independent variables for asthma risk there was a stronger association with serum IgE elevation than skin test reactivity In fact serum IgE tended to be high in asthmatics regardless of skin test reactivity
Omalizumab Xolair is a recombinant humanized monoclonal antibody that binds specifically to the FceRI binding site on human IgE The binding of omalizumab inhibits the ability of IgE to bind to basophils or mast cells
Omalizumab recently received FDA approval for the treatment of moderate to severe persistent allergic asthma in pediatric 12 years of age and above and adult patients The addition of omalizumab to standard asthma therapies has been found to reduce asthma exacerbations and decrease both inhaled corticosteroid dose and rescue medication use Busse 2001 In a phase III double blinded placebo controlled trial involving 525 severe allergic asthmatics omalizumab treated patients had fewer exacerbations during both a steroid stable phase and steroid reduction phase than did placebo controls Busse 2001 The median reduction in steroid dose during reduction phase was 75 and 50 in the omalizumab and placebo groups respectively In a similarly designed steroid reduction study involving 6 to 12 year-old moderate to severe allergic asthmatics steroid reduction was possible in 100 of treated patient verses 667 of placebo treated patients Milgrom 2001 Other steroid reduction studies have had similar results Buhl 2002 Soler 2001 Omalizumab has also been shown to improve quality of life in allergic asthmatics as measured by the Asthma Quality of Life Questionnaire AQLQ In adults AQLQ demonstrated greater improvement at 16 28 and 52 weeks in omalizumab treated patients than in placebo treated Finn 2003 Similarly in pediatric populations AQLQ improvement reached statistical significance in omalizumab treated patients Lemanske 2002
Omalizumab has shown itself to be a promising new therapy for the treatment of moderate to severe allergic asthma It is currently not indicated for patients with non-allergic asthma The objective of this study will be to define the effects of omalizumab on cell surface FceRI expression and serum IgE of non-allergic asthmatics
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