A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

Phase 3

• Conditions: Allergic Conjunctivitis; Allergic Rhinitis
• Interventions: Biological: Placebo; Biological: modified allergen extract

• Registration Number: NCT01012752
• Lead Sponsor: Roxall Medizin

Brief Summary

This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.

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: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
• 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
Placebo	Placebo	-
modified allergen extract	modified 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