Atopic AsthmaPhase 2CIANCT00784459
The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics
A Phase 2 study testing abatacept in people with Atopic Asthma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet all of the following criteria:
- 18 - 50 years of age;
- Previously documented physician-diagnosis of asthma consistent with NAEPP guidelines, with alternative diagnoses (eg, chronic obstructive pulmonary disease) ruled out;
- Forced expiratory volume in one second (FEV1) ≥ 70% of predicted value at screening and at first SAC visit;
- Positive methacholine inhalation challenge test of (PC20) ≤ 8 mg/mL within 6 months or at screening visit;
- History of atopic symptoms by subject self-report (allergic rhinitis, conjunctivitis, or eczema);
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- A positive skin prick or intradermal test to cat allergen extract, short ragweed allergen extract, or dust mite allergen extracts at screening visit. A positive skin test is defined as induration of skin test wheal being ≥ 2 mm greater in diameter than saline control skin wheal;
- After the baseline SAC (V3), subject should demonstrate at least a 50% increase in the percentage of eosinophils (compared to pre-allergen saline) and at least 10% eosinophils in post allergen lavage.
- Stable asthma as reflected by no significant changes in controller asthma medications, no acute asthma exacerbations requiring oral corticosteroids, hospitalizations, emergency room visits, or unscheduled health care provider visits for asthma for at least 4 weeks prior to screening and up through the time of the first dose of study drug;
- No history of intubation for asthma;
- Sexually active women of childbearing potential must use an effective method of birth control during the entire course of the study and for 10 weeks after the final dose of the study drug, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) will be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. All WOCBP MUST have a negative pregnancy test on the day of drug administration prior to receiving each dose. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- Ability to give informed consent (adults must be able to consent for themselves and be literate) and to comply with study procedures.
Who cannot join
- Patients must have none of the following:
- Lung disease other than allergic asthma (eg, chronic bronchitis, COPD);
- Use of chronic oral corticosteroids or inhaled corticosteroids at doses > 440 μg/da fluticasone or equivalent within four weeks prior to screening visit
- Concurrent diseases, finding on physical examination, or screening laboratory studies that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk by participating;
- Upper or lower respiratory tract infections within 4 weeks before screening;
- No febrile illness (>38.0o C or 100.4oF) within 24 hours at screening and through the time of the study drug administration on Study Day 0;
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- Current use of any β-adrenergic antagonist (eg, propranolol)
- Use of long acting beta-agonists (LABA) or long acting muscarinic antagonists (LAMA) within 2 weeks of screening visit.
- Use of theophylline preparations.
- Current allergy immunotherapy within 3 months of screening.
- Use of systemic immunosuppressive drugs including systemic corticosteroids ,within the 4 weeks prior to screening up through administration of study drug;
- Use of any TNFα inhibitor within 12 weeks of administration of study drug.
- Participation in an intervention research study within past 4 weeks or receipt of any investigational drug or biologic(s) within 5 half-lives of the agent prior to the first dose of study drug and through Study Day 154;
- Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus-1 or 2 (HIV-1 or HIV-2), or active infection with hepatitis A;
- History of cancer other than basal cell carcinoma or cervical carcinoma-in-situ that has been treated and cured by conization or other techniques.
- History of primary immunodeficiency;
- History of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to screening or history of smoking of greater than or equal to 10 pack-years;
- History of a positive PPD;
- History of allergic reaction to abatacept or any of the components of the study drug.
- Pregnancy, women that are breast feeding, or that have an intention to become pregnant or breast feed during the time frame of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Costimulation Inhibition in Asthma
This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen challenge (SAC) will be performed. The subjects will be randomized to either placebo or abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary endpoint will be to determine if treatment with abatacept results in a 50% or greater decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid following SAC as compared to placebo control. Secondary endpoints include measures of airway obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of the safety of abatacept administration in this subject population.
Read the detailed description
please see summary
- Conditions
- Atopic Asthma
- Being tested
- abatacept, Placebo
- Keywords
- Asthma, Allergy
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abataceptDrug
Also called Orencia, CTLA4Ig
Treatment with abatacept, 10 mg/kg IV, for 5 doses.
PlaceboDrug
Treatment with Placebo, IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Abatacept | Experimental | Administration of Abatacept intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. Receives: Drug: abatacept |
| Placebo | Placebo comparator | Administration of placebo (normal saline) intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge
collected prior to randomization to abatacept or placebo
Measured: baseline
Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic AsthmaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Jonathan Green, MD, Washington University School of Medicine
- Investigators
- Jonathan Green, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784459
- Sponsor's protocol ID
- 08-0405
- Acronym
- CIA
- Status last verified
- Dec 2013
- First submitted
- 3 Nov 2008
- Last updated
- 5 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parulekar AD, Boomer JS, Patterson BM, Yin-Declue H, Deppong CM, Wilson BS, Jarjour NN, Castro M, Green JM. A randomized controlled trial to evaluate inhibition of T-cell costimulation in allergen-induced airway inflammation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):494-501. doi: 10.1164/rccm.201207-1205OC. Epub 2013 Jan 4.
PubMed 23292882
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costimulation Inhibition in Asthma
- ClinicalTrials.gov ID
- NCT00784459
- Acronym / sponsor ID
- CIA / 08-0405
- Conditions
- Atopic Asthma
- Keywords
- Asthma, Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 5 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen challenge (SAC) will be performed. The subjects will be randomized to either placebo or abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary endpoint will be to determine if treatment with abatacept results in a 50% or greater decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid following SAC as compared to placebo control. Secondary endpoints include measures of airway obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of the safety of abatacept administration in this subject population.
Detailed description
please see summary
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Abatacept | Experimental | Drug: abataceptAdministration of Abatacept intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo (normal saline) intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18 - 50 years of age;
- Previously documented physician-diagnosis of asthma consistent with NAEPP guidelines, with alternative diagnoses (eg, chronic obstructive pulmonary disease) ruled out;
- Forced expiratory volume in one second (FEV1) ≥ 70% of predicted value at screening and at first SAC visit;
- Positive methacholine inhalation challenge test of (PC20) ≤ 8 mg/mL within 6 months or at screening visit;
- History of atopic symptoms by subject self-report (allergic rhinitis, conjunctivitis, or eczema);
Key exclusion criteria (20 listed)
- Lung disease other than allergic asthma (eg, chronic bronchitis, COPD);
- Use of chronic oral corticosteroids or inhaled corticosteroids at doses > 440 μg/da fluticasone or equivalent within four weeks prior to screening visit
- Concurrent diseases, finding on physical examination, or screening laboratory studies that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk by participating;
- Upper or lower respiratory tract infections within 4 weeks before screening;
- No febrile illness (>38.0o C or 100.4oF) within 24 hours at screening and through the time of the study drug administration on Study Day 0;
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 |
|---|---|---|
| abataceptAlso: Orencia, CTLA4IgTreatment with abatacept, 10 mg/kg IV, for 5 doses. | Drug | Treatment with Abatacept |
| PlaceboTreatment with Placebo, IV | Drug | Placebo |
Primary outcome
Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge
Time frame: baseline
collected prior to randomization to abatacept or placebo
Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23292882Parulekar AD, Boomer JS, Patterson BM, Yin-Declue H, Deppong CM, Wilson BS, Jarjour NN, Castro M, Green JM. A randomized controlled trial to evaluate inhibition of T-cell costimulation in allergen-induced airway inflammation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):494-501. doi: 10.1164/rccm.201207-1205OC. Epub 2013 Jan 4.
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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.
Jonathan Green, MD principal investigator
Washington University School of Medicine
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 abatacept in people with Atopic Asthma, run by Washington University School of Medicine 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 12 inclusion and 20 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 5 Feb 2014. 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. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT00784459, 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 5 Feb 2014.