Multicenter Trial of Immunotherapy With House Dust Mite Allergoid (ACRI)

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Rhinoconjunctivitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540631

AL0106ac

2006-000934-11 (EudraCT Number)

Details and patient eligibility

About

Multicenter Immunotherapy House Dust Mite Allergoid

Full description

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

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive SPT
• Positive EAST
• Positive specific provocation test

Exclusion criteria

• Serious chronic diseases
• other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

P

No Intervention group

Description:

subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals

A

Experimental group

Description:

Active treatment with house dust mite extract

Treatment:

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