|
Recombinant Human IL-4 Receptor Used in Treatment of Asthma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Recombinant Human IL-4 Receptor Used in Treatment of Asthma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Recombinant Human IL-4 Receptor Used in Treatment of Asthma Clinical research trials and Recombinant Human IL-4 Receptor Used in Treatment of Asthma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Recombinant Human IL-4 Receptor Used in Treatment of Asthma. Recombinant Human IL-4 Receptor Used in Treatment of Asthma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Recombinant Human IL-4 Receptor Used in Treatment of Asthma clinical trial. Participants oftentimes recieve the finest healthcare available for their Recombinant Human IL-4 Receptor Used in Treatment of Asthma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Recombinant Human IL-4 Receptor Used in Treatment of Asthma  Recombinant Human IL-4 Receptor Used in Treatment of Asthma
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Immunex Corporation ,
Synopsis: 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. 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 12 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 12 to 85 years of age (consent of parent or guardian required if under 18 years). - Have continuous asthma and are being treated with albuterol MDI only. - Have reduced lung functions. - Have a positive reaction to 2 substances as demonstrated with a skin test. - Have been a nonsmoker for at least 2 years and have not smoked more than 1 pack a day for 5 years or less. - Agree to use contraception throughout the study. - Agree not to donate blood throughout the study. - Are able to use correctly an aerosol drug delivery device. - Have had an asthma attack on at least 3 of the last 7 days. Exclusion Criteria Patients will not be eligible for this study if they: - Had asthma requiring hospitalization within 6 weeks of beginning study treatment. - Had asthma requiring emergency room treatment within 12 months of beginning study treatment. - Had a respiratory infection that affected asthma within 2 weeks of beginning study treatment. - Had a breathing tube inserted for asthma treatment within 15 years of beginning study treatment. - Were previously enrolled in a study of soluble IL-4 receptor. - Have drug abuse, alcohol abuse, or a mental illness that may interfere with the study. - Have serious medical problems (such as heart or lung problems, uncontrolled high blood pressure, are overweight to the extent that ability to breathe is affected, or have cancer other than skin cancer), diabetes, autoimmune diseases, or HIV. - Are pregnant or breast-feeding. - Have used certain drugs.
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
HaroldNelson, Principal Investigator,
Additional Information:
Study ID Numbers: DAIT Asthma 013.0014;
Study Start Date: April 1999
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017693
Other Asthma Studies:
1. Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
2. Long-term Safety Performance of Fexofenadine in Asthma
3. The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma
4. Magnesium and Asthma - Clinical Trials
5. Self Management Education Asthma
Related Studies:
Other Asthma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
|
|
|
|
|
|
|
|
