Recombinant Human IL-4 Receptor Used in Treatment of Asthma

NCT ID: NCT00017693

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2000-02-29

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.

Detailed Description

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.75mg rsIL-4R

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.

Group Type: EXPERIMENTAL

Recombinant human soluble IL-4 receptor

Intervention Type: BIOLOGICAL

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)

1.5mg rsIL-4R

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.

Group Type: EXPERIMENTAL

Recombinant human soluble IL-4 receptor

Intervention Type: BIOLOGICAL

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)

3.0mg rsIL-4R

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.

Group Type: EXPERIMENTAL

Recombinant human soluble IL-4 receptor

Intervention Type: BIOLOGICAL

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)

Placebo for rsIL-4R

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.

Group Type: PLACEBO_COMPARATOR

Placebo for Recombinant human soluble IL-4 receptor

Intervention Type: BIOLOGICAL

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

Interventions

Recombinant human soluble IL-4 receptor

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)

Intervention Type: BIOLOGICAL

Placebo for Recombinant human soluble IL-4 receptor

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Placebo Treatment

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunex Corporation

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Borish, MD

Role: STUDY_CHAIR

University of Virginia

Harold Nelson, MD

Role: STUDY_CHAIR

National Jewish Health

References

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.

Reference Type: RESULT

PMID: 11398072 (View on PubMed)

Related Links

http://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

Other Identifiers

DAIT Asthma 013.0014

Identifier Type: -

Identifier Source: org_study_id

NCT00016705

Identifier Type: -

Identifier Source: nct_alias