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

Fresenius Medical Care (FMC)

Status

Completed

Conditions

Allergic Asthma

Treatments

Device: IgE adsorber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02096237

TA-IgE-01-A

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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