Recombinant Human IL-4 Receptor Used in Treatment of Asthma

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00017693
First received: June 7, 2001
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Biological: Recombinant Recombinant human soluble IL-4 receptor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change from baseline in Forced expiratory volume in 1 second (FEV1) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: April 1999
Study Completion Date: February 2000
Arms Assigned Interventions
Experimental: 0.75mg Recombinant human soluble IL-4 receptor
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 Recombinant human soluble IL-4 receptor
Experimental: 1.5mg Recombinant human soluble IL-4 receptor
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 Recombinant human soluble IL-4 receptor
Experimental: 3.0mg Recombinant human soluble IL-4 receptor
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 Recombinant human soluble IL-4 receptor
Placebo Comparator: Placebo for Recombinant human soluble IL-4 receptor
The placebo 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017693

Sponsors and Collaborators
Immunex Corporation
Investigators
Study Chair: Larry Borish, MD University of Virginia
Study Chair: Harold Nelson, MD National Jewish Health
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00017693     History of Changes
Obsolete Identifiers: NCT00016705
Other Study ID Numbers: DAIT Asthma 013.0014
Study First Received: June 7, 2001
Last Updated: January 16, 2013
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Recombinant Proteins
Aerosols
Asthma
Receptors, Interleukin-4
Forced Expiratory Volume

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Interleukin-4
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 01, 2014