AsthmaPhase 2NCT00001893
Study of TNFR:Fc (Enbrel) in the Treatment of Asthma
A Phase 2 study testing TNFR:Fc in people with Asthma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- TNFR:Fc
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 1999to 31 Dec 2002
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be between 18 and 65 years of age, male or female, and must be at least 5 feet in height.
- The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation.
- Patients will have mild-to-moderate allergic asthma as defined by a baseline forced expiratory flow in one second (FEV(1)) greater than 70% of predicted (at least 6 hours after bronchodilator use) and therapy limited to inhaled beta-agonists.
- Patients must be without evidence of an asthma exacerbation or a viral upper respiratory tract infection for 6 weeks prior to entry into the study.
- Positive skin prick-puncture test to one or more common aeroallergens.
- A positive inhaled methacholine challenge as defined by a decrease in FEV(1) of at least 20% (PC20) in response to inhalation of less than 25 mg/ml of methacholine.
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- A decrease in FEV(1) of at least 20% in response to inhalation of up to 10,000 bioequivalency allergy units (BAU) or allergy units (AU) per ml of a selected common aeroallergen (house dust mite, cat hair or grasses) or up to 150 Antigen E units per ml of short ragweed. Asthmatic patients must also demonstrate a late asthmatic response (defined as a 20% fall from the baseline established following completion of the early asthmatic response).
- Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels (less than 30 ml of blood will be drawn), normal EKG and chest radiograph without acute pulmonary infiltrates.
- For women of childbearing potential, negative pregnancy test with 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Clinical Trial of TNFR:Fc in a Segmental Allergen Challenge Model of Asthma
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.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- TNFR:Fc
- Keywords
- Bronchoprovocation, Airway Inflammation, Tumor Necrosis Factor, Bronchoalveolar Lavage, Pulmonary Function Test, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFR:FcDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether subcutaneous administration of TNFR:Fc alters TNF bioactivity in brochoalveolar lavage fluid (BALF) samples.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start17 Aug 1999
- Primary completion31 Dec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001893
- Sponsor's protocol ID
- 990140
- Other IDs
- 99-H-0140
- Status last verified
- 13 Jun 2008
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Broide DH, Lotz M, Cuomo AJ, Coburn DA, Federman EC, Wasserman SI. Cytokines in symptomatic asthma airways. J Allergy Clin Immunol. 1992 May;89(5):958-67. doi: 10.1016/0091-6749(92)90218-q.
PubMed 1374772
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of TNFR:Fc in a Segmental Allergen Challenge Model of Asthma
- ClinicalTrials.gov ID
- NCT00001893
- Acronym / sponsor ID
- 990140
- Conditions
- Asthma
- Keywords
- Bronchoprovocation, Airway Inflammation, Tumor Necrosis Factor, Bronchoalveolar Lavage, Pulmonary Function Test, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 17 Aug 1999
- Primary completion
- 31 Dec 2002 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients will be between 18 and 65 years of age, male or female, and must be at least 5 feet in height.
- The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation.
- Patients will have mild-to-moderate allergic asthma as defined by a baseline forced expiratory flow in one second (FEV(1)) greater than 70% of predicted (at least 6 hours after bronchodilator use) and therapy limited to inhaled beta-agonists.
- Patients must be without evidence of an asthma exacerbation or a viral upper respiratory tract infection for 6 weeks prior to entry into the study.
- Positive skin prick-puncture test to one or more common aeroallergens.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNFR:Fc | Drug | – |
Primary outcome
Whether subcutaneous administration of TNFR:Fc alters TNF bioactivity in brochoalveolar lavage fluid (BALF) samples.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1374772Broide DH, Lotz M, Cuomo AJ, Coburn DA, Federman EC, Wasserman SI. Cytokines in symptomatic asthma airways. J Allergy Clin Immunol. 1992 May;89(5):958-67. doi: 10.1016/0091-6749(92)90218-q.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNFR:Fc in people with Asthma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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 9 inclusion and 21 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Whether subcutaneous administration of TNFR:Fc alters TNF bioactivity in brochoalveolar lavage fluid (BALF) samples. (time frame: 3 years). 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 NCT00001893, 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 2 Jul 2017.