Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

ROXALL

Status and phase: Unknown; Phase 3

Conditions: Allergic Rhinitis

Treatments: Biological: modified allergen extract of house dust mites; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013116

SBC-2009-002B

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive history of perennial allergic rhinitis due to house dust mites
• Positive screening skin prick test (wheal diameter > 3 mm)
• Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
• Signed and dated patient´s Informed Consent,

Exclusion criteria

• Previous immunotherapy with mite extracts within the last 3 years,
• Simultaneous participation in other clinical trials,
• Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
• Auto-immune disorders,
• Severe chronic inflammatory diseases,
• Malignancy,
• Alcohol abuse,
• Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
• Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

modified allergen extract of house dust mites

Experimental group

Treatment:

Biological: modified allergen extract of house dust mites

Placebo

Placebo Comparator group

Treatment:

Biological: placebo