Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Respiratory Hypersensitivity

Treatments: Biological: Acaroid; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00263640

2004-003892-35 (EudraCT Number)

Al0104av

Details and patient eligibility

About

The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.

Full description

The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.

Enrollment: 130 patients

Sex: All

Ages: 6 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bronchial asthma
• Requirements for inhaled corticosteroid
• Positive skin prick test to house dust mite
• Positive radioallergosorbent test (RAST) to house dust mite
• Positive provocation test result to house dust mite

Exclusion criteria

• Serious chronic diseases
• Other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.

Treatment:

Drug: Placebo

Acaroid

Experimental group

Description:

The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.

Treatment:

Biological: Acaroid