Study of TNFR:Fc (Enbrel) in the Treatment of Asthma

Completed · Phase 2

Conditions studied: Asthma

In brief

The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen bronchoprovocation model of atopic asthma. The goal of this study is to assess whether inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind, placebo-controlled trial design. TNF bioactivity will be inhibited via systemic administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the utility of anti-TNF therapy for patients with asthma.

Key facts

Study ID

NCT00001893

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

150

Starts

1999-08-17

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Hypersensitivity to TNFR:Fc
• Women who are breast-feeding infants will be excluded because the risk of a serious adverse reaction in the infants to TNFR:Fc is unknown.
• Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).
• Respiratory tract infection or asthma exacerbation within 4 weeks of screening.
• Presence of an active infection.
• Use of theophylline, oral or inhaled corticosteroid, nedocromil sodium, cromolyn sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or anti-cholinergic agents within the prior 3 months. In addition, patients requiring ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be excluded. Research subjects can continue therapy with inhaled beta-agonists during the study.
• History of anaphylaxis or severe allergic response.
• History of adverse reactions to lidocaine or other local anesthetics.
• Use of aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study.
• History of cigarette smoking within the past 3 years.
• History of allergy immunotherapy within the past year.
• Allergy to methacholine.
• Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation).
• Positive test for hepatitis viruses (to exclude patients with hepatitis-related lung disease, such as pleural effusions, interstitial pneumonitis and fibrosis).
• History of Crohn's disease (to exclude patients with inflammatory bowel disease-related alveolar lymphocytosis).
• History of diseases associated with impaired host defenses, such as diabetes mellitus or congestive heart failure. Patients with impaired host defenses also include individuals with either acquired or congenital, quantitative or qualitative defects in neutrophil, lymphocyte, monocyte/macrophage or complement function. Similarly, patients requiring immunosuppressive therapies, such as a chronic corticosteroid utilization for more than 6 months or cytoxic chemotherapeutic agents will be excluded.
• History of chronic heart failure or coronary artery disease.
• History of central nervous system demyelinating disorders, such as multiple sclerosis, myelitis or optic neuritis.
• History of hematologic disorders, such as anemia (other than iron deficiency anemia), thrombocytopenia or leukopenia.
• History of renal disease, such as chronic renal failure or renal artery stenosis with renal artery stent placement.
• History of psoriasis.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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