Recombinant Human IL-4 Receptor Used in Treatment of Asthma

March 3, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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)
Experimental: 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.
Biological: 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)
Experimental: 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.
Biological: 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)
Placebo Comparator: 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.
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
Other Names:
  • Placebo Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Forced expiratory volume in 1 second (FEV1)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immunex Corporation

Investigators

  • Study Chair: Larry Borish, MD, University of Virginia
  • Study Chair: Harold Nelson, MD, National Jewish Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

February 1, 2000

Study Completion (Actual)

February 1, 2000

Study Registration Dates

First Submitted

June 7, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT Asthma 013.0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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