Efficacy and Safety of Sublingual Immunotherapy (SLIT)

Phase 3

• Conditions: Allergic Rhinitis
• Interventions: Biological: sublingual immunotherapy with placebo; Biological: sublingual immunotherapy with allergen extract

• Registration Number: NCT01012882
• Lead Sponsor: Roxall Medizin

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03
• Study Start: 2016-11
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sublingual application of placebo	sublingual immunotherapy with placebo	-
sublingual application of allergen extract	sublingual immunotherapy with allergen extract	-

Primary Outcome Measures

Name	Time	Method
Symptom and medication score	1 year

Secondary Outcome Measures

Name	Time	Method
Safety of the treatment	1 year
Documentation of adverse events	1 year
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	1 year
Clinical global improvement	1 year

Trial Locations

Locations (1)

Roxall Medizin; 🇩🇪 Hamburg, Germany