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AsthmaPhase 2NCT00017693

Recombinant Human IL-4 Receptor Used in Treatment of Asthma

A Phase 2 study testing Recombinant human soluble IL-4 receptor in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 85 years
Conditions the study is for
Asthma
What is being tested?
Recombinant human soluble IL-4 receptor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
No sites listed yet
Study dates
May 1998to Feb 2000
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: 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.

Read the 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
Being tested
Recombinant human soluble IL-4 receptor, Placebo for Recombinant human soluble IL-4 receptor
Keywords
Recombinant Proteins, Aerosols, Asthma, Receptors, Interleukin-4, Forced Expiratory Volume
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant human soluble IL-4 receptorBiological

    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 Recombinant human soluble IL-4 receptorBiological

    Also called Placebo Treatment

    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

Study groups in NCT00017693
Study groupRoleWhat they receive
0.75mg rsIL-4RExperimentalRecombinant 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.
Receives: Biological: Recombinant human soluble IL-4 receptor
1.5mg rsIL-4RExperimentalRecombinant 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.
Receives: Biological: Recombinant human soluble IL-4 receptor
3.0mg rsIL-4RExperimentalRecombinant 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.
Receives: Biological: Recombinant human soluble IL-4 receptor
Placebo for rsIL-4RPlacebo comparatorThe 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.
Receives: Biological: Placebo for Recombinant human soluble IL-4 receptor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study startMay 1998
  3. Primary completionFeb 2000
  4. Study completionFeb 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017693
Sponsor's protocol ID
DAIT Asthma 013.0014
Status last verified
Mar 2016
First submitted
7 Jun 2001
Last updated
7 Mar 2016
Results posted
No

Publications

  • 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.

    PubMed 11398072

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant human soluble IL-4 receptor in people with Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Forced expiratory volume in 1 second (FEV1) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00017693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.

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