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Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study) (ESPIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02096237
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Device: IgE adsorber Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: apheresis, IgE adsorber
9 apheresis treatments with the new IgE adsorber in a period of 3 months with 3 cycles of 3 treatments each every month.
Device: IgE adsorber
Two plasma volumes of each patient in the apheresis group will be treated per session

No Intervention: Conventional drug treatment
Patients treated with conventional asthma treatment as prescribed before study entry. No intervention in prescription



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096237


Locations
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Austria
Medical University Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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Principal Investigator: Kurt Derfler, Prof. Dr. Dep. of Internal Medicine III, Nephrology and Dialysis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT02096237    
Other Study ID Numbers: TA-IgE-01-A
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Fresenius Medical Care Deutschland GmbH:
asthma, bronchial
immunoadsorbents
apheresis
immunoglobulin E
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases