Allergic AsthmaESPIRANCT02096237
Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study)
A study testing IgE adsorber in people with Allergic Asthma, run by Fresenius Medical Care Deutschland GmbH at 1 site in Austria.
Trial summary
In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- IgE adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to Nov 2014
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed Informed Consent
- Clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, IgE serology
- Allergic asthma (diagnosed by lung specialist)
- IgE concentration in blood at least 300 kilo Units (kU)/L
Who cannot join
- Participation in another trial within 30 days prior to enrolment
- Gravidity (pregnancy test prior to each treatment cycle)
- Intake of omalizumab
- Hepatitis or HIV or malignant disease
- Specific immunotherapy in the last 6 months
- Non-allergic asthma
Show all 19Show fewer
- Auto-immune diseases
- Hypocalcaemia
- Intake of ACE-inhibitors (discontinuation according to half-time before treatment possible)
- Uncontrolled bleeding and coagulation disorders
- Severe cardiovascular disease
- Severe cardiac arrhythmias
- Severe systemic infection
- Unability to tolerate therapeutic apheresis procedures (hypersensitivity associated with previous apheresis sessions)
- Inadequate peripheral venous access
- Condition in which acute fluid shifts may cause congestive heart failure
- Established or suspected intra-cranial disease where fluid imbalance or pressure changes could exacerbate the disease
- Impaired renal function
- Clinically significant hypotension or borderline hypotension where a further drop in blood pressure could be harmful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber
In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.
- Conditions
- Allergic Asthma
- Being tested
- IgE adsorber
- Keywords
- asthma, bronchial, immunoadsorbents, apheresis, immunoglobulin E
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgE adsorberDevice
Two plasma volumes of each patient in the apheresis group will be treated per session
| Study group | Role | What they receive |
|---|---|---|
| apheresis, IgE adsorber | Experimental | 9 apheresis treatments with the new IgE adsorber in a period of 3 months with 3 cycles of 3 treatments each every month. Receives: Device: IgE adsorber |
| Conventional drug treatment | No intervention | Patients treated with conventional asthma treatment as prescribed before study entry. No intervention in prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of IgE concentration in Plasma/Serum
Decrease in IgE concentrations from before the first apheresis treatment (in the control group the first blood sampling) to after the last apheresis treatment after three months (in the control group last blood sampling after three months)
Measured: Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionNov 2014
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 Allergic AsthmaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Derfler, Prof. Dr., Principal investigator, Dep. of Internal Medicine III, Nephrology and Dialysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096237
- Sponsor's protocol ID
- TA-IgE-01-A
- Acronym
- ESPIRA
- Status last verified
- Mar 2015
- First submitted
- 21 Mar 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lupinek C, Derfler K, Lee S, Prikoszovich T, Movadat O, Wollmann E, Cornelius C, Weber M, Froschl R, Selb R, Blatt K, Smiljkovic D, Schoder V, Cervenka R, Plaichner T, Stegfellner G, Huber H, Henning R, Kozik-Jaromin J, Perkmann T, Niederberger V, Petkov V, Valent P, Gauly A, Leinenbach HP, Uhlenbusch-Koerwer I, Valenta R. Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy. EBioMedicine. 2017 Mar;17:119-133. doi: 10.1016/j.ebiom.2017.02.007. Epub 2017 Feb 12.
PubMed 28254561
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber
- ClinicalTrials.gov ID
- NCT02096237
- Acronym / sponsor ID
- ESPIRA / TA-IgE-01-A
- Conditions
- Allergic Asthma
- Keywords
- asthma, bronchial, immunoadsorbents, apheresis, immunoglobulin E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Mar 2014 (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.
In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apheresis, IgE adsorber | Experimental | Device: IgE adsorber9 apheresis treatments with the new IgE adsorber in a period of 3 months with 3 cycles of 3 treatments each every month. |
| Conventional drug treatment | No intervention | –Patients treated with conventional asthma treatment as prescribed before study entry. No intervention in prescription |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Informed Consent
- Clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, IgE serology
- Allergic asthma (diagnosed by lung specialist)
- IgE concentration in blood at least 300 kilo Units (kU)/L
Key exclusion criteria (19 listed)
- Participation in another trial within 30 days prior to enrolment
- Gravidity (pregnancy test prior to each treatment cycle)
- Intake of omalizumab
- Hepatitis or HIV or malignant disease
- Specific immunotherapy in the last 6 months
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 |
|---|---|---|
| IgE adsorberTwo plasma volumes of each patient in the apheresis group will be treated per session | Device | apheresis, IgE adsorber |
Primary outcome
Reduction of IgE concentration in Plasma/Serum
Time frame: Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months
Decrease in IgE concentrations from before the first apheresis treatment (in the control group the first blood sampling) to after the last apheresis treatment after three months (in the control group last blood sampling after three months)
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 6 Mar 2015.
- Derived from this study: PubMed 28254561Lupinek C, Derfler K, Lee S, Prikoszovich T, Movadat O, Wollmann E, Cornelius C, Weber M, Froschl R, Selb R, Blatt K, Smiljkovic D, Schoder V, Cervenka R, Plaichner T, Stegfellner G, Huber H, Henning R, Kozik-Jaromin J, Perkmann T, Niederberger V, Petkov V, Valent P, Gauly A, Leinenbach HP, Uhlenbusch-Koerwer I, Valenta R. Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy. EBioMedicine. 2017 Mar;17:119-133. doi: 10.1016/j.ebiom.2017.02.007. Epub 2017 Feb 12.
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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.
Kurt Derfler, Prof. Dr. principal investigator
Dep. of Internal Medicine III, Nephrology and Dialysis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IgE adsorber in people with Allergic Asthma, run by Fresenius Medical Care Deutschland GmbH at 1 site in Austria.
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 4 inclusion and 19 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 6 Mar 2015. 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 Austria. 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.
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?
Reduction of IgE concentration in Plasma/Serum (time frame: Before first treatment (baseline) to after the last of 9 treatments over a time period of 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 NCT02096237, 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 6 Mar 2015.