NCT00017693|CompletedPhase 2
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
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Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
Sponsor study identifier
interventional
62
0 countries
N/A
Study Start
May 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2000
Actual (reported)Study Completion
February 2000
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2000
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1998
Date type not reportedThis date has not been verified as actual or estimated.
February 2000
Actual (reported)February 2000
Actual (reported)June 7, 2001
Actual (reported)August 31, 2001
Actual (reported)Change from baseline in Forced expiratory volume in 1 second (FEV1)
3 months
Recombinant 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.
Recombinant 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.
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)
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.
Larry Borish, MD
University of Virginia
Harold Nelson, MD
National Jewish Health
62 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2001
First Posted
August 31, 2001
Study Start
May 1998
Date type not reportedThis date has not been verified as actual or estimated.
Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents
Recombinant 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.
The 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.
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
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Primary Completion
February 2000
Actual (reported)Study Completion
February 2000
Actual (reported)Last Updated
March 7, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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