Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

ROXALL

Status and phase: Unknown; Phase 3

Conditions: Allergic Rhinitis

Treatments: Biological: Placebo; Biological: Allergen extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014325

SLG-2009-006B

Details and patient eligibility

About

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive history of perennial allergic rhinitis
• 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 allergen 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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130 participants in 2 patient groups, including a placebo group

Allergen extract

Experimental group

Treatment:

Biological: Allergen extract

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo