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

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.

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Key information

Conditions

Allergic Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna

Vienna, A-1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IgE adsorber

Device

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

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber

Acronym: ESPIRA

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 26, 2014
Registry last updated: Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed