Asthma Clinical Trial
Official title:
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor
(IL-4R) in treating asthma.
Asthma can be caused by the allergic response from breathing in certain irritants.
Interleukin 4 (IL-4), which is naturally produced by the body, plays a major role in this
allergic response. Doctors feel that IL-4 activity may be stopped by giving IL-4R, a product
that binds to IL-4, and thereby decrease the problems of asthma.
A major factor in the pathogenesis of asthma is the development of an allergic inflammatory
response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this response.
Binding and inactivating the IL-4 molecule with IL-4R may diminish the allergic asthmatic
response by inhibiting activities of IL-4.
Patients are randomized to 1 of 3 treatment groups and, within each group, are stratified by
baseline FEV1 cohort. Patients receive either dose level 1 of IL-4R, dose level 2 of IL-4R,
or placebo, by aerosol drug delivery device, once a week for 12 weeks. There are frequent
clinic visits and several follow-up visits. Physical exams and spirometry are done
regularly; immunizations are administered on Day 28; and a skin tests panel is given on Day
84. Blood samples are collected at study visits during treatment and follow-up to test for
immunology/serology parameters, chemistry profiles, and asthma-related DNA polymorphisms.
Patients are provided with peak flow meters and must demonstrate their proper use so that a
peak expiratory flow (PEF) diary and a symptoms diary can be maintained. Selected sites
measure exhaled nitric oxide and collect induced sputum samples. Assessments for adverse
events are conducted at 16 and 40 weeks following the first study drug treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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