Efficacy and Safety of Sublingual Immunotherapy (SLIT)

Allergic Rhinitis Clinical Trial

Official title:

A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01012882
• Other study ID #: SLG-2009-005B
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: November 2, 2015
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Roxall Medizin
• Contact: Roxall Medizin
• Phone: 0049408972520
• Email: info[@]roxall.de
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• sublingual immunotherapy with allergen extract
sublingual application
• sublingual immunotherapy with placebo
sublingual application

Locations

Country	Name	City	State
Germany	Roxall Medizin	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom and medication score		1 year	Yes
Secondary	Safety of the treatment		1 year	Yes
Secondary	Documentation of adverse events		1 year	Yes
Secondary	Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)		1 year	Yes
Secondary	Clinical global improvement		1 year	Yes