Recombinant Human IL-4 Receptor Used in Treatment of Asthma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Recombinant human soluble IL-4 receptor

Placebo for Recombinant human soluble IL-4 receptor

About this trial

This is an interventional treatment trial for Asthma focused on measuring Recombinant Proteins, Aerosols, Asthma, Receptors, Interleukin-4, Forced Expiratory Volume

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

0.75mg rsIL-4R

1.5mg rsIL-4R

3.0mg rsIL-4R

Placebo for rsIL-4R

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in Forced expiratory volume in 1 second (FEV1)

Secondary Outcome Measures

Full Information

NCT ID

NCT00017693

First Posted

June 7, 2001

Last Updated

March 3, 2016

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immunex Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00017693

Brief Title

Recombinant Human IL-4 Receptor Used in Treatment of Asthma

Official Title

Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

February 2000 (Actual)

Study Completion Date

February 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immunex Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Recombinant Proteins, Aerosols, Asthma, Receptors, Interleukin-4, Forced Expiratory Volume

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.75mg rsIL-4R

Arm Type

Experimental

Arm Description

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.

Arm Title

1.5mg rsIL-4R

Arm Type

Experimental

Arm Description

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.

Arm Title

3.0mg rsIL-4R

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo for rsIL-4R

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Recombinant human soluble IL-4 receptor

Intervention Description

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

Intervention Name(s)

Placebo for Recombinant human soluble IL-4 receptor

Other Intervention Name(s)

Placebo Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in Forced expiratory volume in 1 second (FEV1)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Larry Borish, MD

Organizational Affiliation

University of Virginia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Harold Nelson, MD

Organizational Affiliation

National Jewish Health

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

11398072

Citation

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.

Results Reference

result

Links:

URL

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

Description

National Institute of Allergy and Infectious Diseases (NIAID)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial