Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Allergopharma GmbH & Co. KG108 enrolled

Overview

Multicenter Immunotherapy House Dust Mite Allergoid

A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Rhinoconjunctivitis

Interventions

specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)BIOLOGICAL

Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Positive SPT * Positive EAST * Positive specific provocation test Exclusion Criteria: * Serious chronic diseases * other perennial allergies

Locations (1)

Allergopharma GmbH & Co. KG

Reinbek, Germany

Outcomes

Primary Outcomes

The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline

Time frame: November 2007 - February 2010

Secondary Outcomes

Change of the AUC of the SMS after one year to baseline.

Time frame: 1 year

Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline

Time frame: 2 years

Immunologic changes IgE, IgG1 and IgG4

Time frame: 2 years

Tolerability and safety of treatments during the entire study period

Time frame: 4 years

Data from ClinicalTrials.gov

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