Efficacy and Safety of Sublingual Immunotherapy (SLIT)

ROXALL

Status and phase: Unknown; Phase 3

Conditions: Allergic Rhinitis

Treatments: Biological: sublingual immunotherapy with allergen extract; Biological: sublingual immunotherapy with placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012882

SLG-2009-005B

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive history of allergen specific seasonal 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 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

---

120 participants in 2 patient groups, including a placebo group

sublingual application of allergen extract

Experimental group

Treatment:

Biological: sublingual immunotherapy with allergen extract

sublingual application of placebo

Placebo Comparator group

Treatment:

Biological: sublingual immunotherapy with placebo