Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

ALK-Abelló

Status and phase: Completed; Phase 4

Conditions: Allergic Asthma

Treatments: Biological: Pangramin Plus D. pteronyssinus 100%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492076

E04/05/PP-M

Details and patient eligibility

About

The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

Full description

The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Enrollment: 45 patients

Sex: All

Ages: 14 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild/moderate persistent asthma
• Positive skin prick test or specific IgE to mites
• Age: 14-55 years old

Exclusion criteria

• Immunotherapy contraindications
• Allergy to other inhalant allergens
• Previous immunotherapy (5 years)with mites

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Pangramin Plus Dermatophagoides pteronyssinus 100%

Treatment:

Biological: Pangramin Plus D. pteronyssinus 100%

2

Placebo Comparator group

Description:

Pangramin Plus placebo

Treatment:

Biological: Pangramin Plus D. pteronyssinus 100%