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

NCT02096237 | Completed

• 1 other identifier: TA-IgE-01-A
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma

Keywords

asthma, bronchial; immunoadsorbents; apheresis; immunoglobulin E

Outcome Measures

Primary Outcomes (1)

• 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)

  Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months

Study Arms (2)

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.

Device: IgE adsorber

Conventional drug treatment

NO INTERVENTION

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

Interventions

IgE adsorber DEVICE

Two plasma volumes of each patient in the apheresis group will be treated per session

apheresis, IgE adsorber

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (1)

Medical University Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 28254561 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kurt Derfler, Prof. Dr.

  Dep. of Internal Medicine III, Nephrology and Dialysis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

AU (1)