Recombinant Human IL-4 Receptor Used in Treatment of Asthma
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
1 other identifier
interventional
62
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started May 1998
Typical duration for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 7, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 7, 2016
March 1, 2016
1.8 years
June 7, 2001
March 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Forced expiratory volume in 1 second (FEV1)
3 months
Study Arms (4)
0.75mg rsIL-4R
EXPERIMENTALRecombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
1.5mg rsIL-4R
EXPERIMENTALRecombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
3.0mg rsIL-4R
EXPERIMENTALRecombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
Placebo for rsIL-4R
PLACEBO COMPARATORThe placebo for recombinant human soluble IL-4 receptor (rsIL-4R) consisted of identically prepared excipient in the same volume (2.5 mL). To maintain blinding, medication was dispensed by an individual who was not responsible for patient care or assessment. Treatment assignment was blinded to all personnel involved in direct conduct or monitoring of the study.
Interventions
Subjects were randomized to twelve once weekly nebulizations of 0.75, 1.5, or 3.0 mg dose of recombinant human soluble IL-4 receptor (rsIL-4R)
Subjects were randomized to twelve once weekly nebulizations of placebo for recombinant human soluble IL-4 receptor (rsIL-4R). Identically prepared (to the recombinant human soluble IL-4 receptor) in the same volume
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Borish LC, Nelson HS, Corren J, Bensch G, Busse WW, Whitmore JB, Agosti JM; IL-4R Asthma Study Group. Efficacy of soluble IL-4 receptor for the treatment of adults with asthma. J Allergy Clin Immunol. 2001 Jun;107(6):963-70. doi: 10.1067/mai.2001.115624.
PMID: 11398072RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Larry Borish, MD
University of Virginia
- STUDY CHAIR
Harold Nelson, MD
National Jewish Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2001
First Posted
August 31, 2001
Study Start
May 1, 1998
Primary Completion
February 1, 2000
Study Completion
February 1, 2000
Last Updated
March 7, 2016
Record last verified: 2016-03