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

Study Overview
=================
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.

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

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Device: IgE adsorber


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apheresis, IgE adsorber<br>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<br>* Two plasma volumes of each patient in the apheresis group will be treated per session<br>|
| No Intervention: Conventional drug treatment<br>Patients treated with conventional asthma treatment as prescribed before study entry. No intervention in prescription | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, bronchial, immunoadsorbents, apheresis, immunoglobulin E