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

Allergic Asthma Clinical Trial

— ESPIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096237
• Other study ID #: TA-IgE-01-A
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: March 5, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Device:
• IgE adsorber
Two plasma volumes of each patient in the apheresis group will be treated per session

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No