Efficacy and Safety of Sublingual Immunotherapy (SLIT)

NCT01012882 — Phase 3, Unknown, 120 participants, Roxall Medizin

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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

Registry	NCT01012882
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	120 (Estimated)
Sponsor	Roxall Medizin (Industry)
Conditions	Allergic Rhinitis
Interventions	sublingual immunotherapy with allergen extract, sublingual immunotherapy with placebo (Biological)
Dates	start 2016-11-01, primary completion 2017-11-01 (estimated), completion 2017-11-01 (estimated), first posted 2009-11-13, last updated 2015-11-03
Locations	1 site in Germany

-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 .

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+Arms and interventions

Arm	Type	Interventions	Description
sublingual application of allergen extract	Experimental	Biological: sublingual immunotherapy with allergen extract
sublingual application of placebo	Placebo comparator	Biological: sublingual immunotherapy with placebo

sublingual immunotherapy with allergen extract (Biological): sublingual application
sublingual immunotherapy with placebo (Biological): sublingual application

+Outcome measures

Primary outcomes

Symptom and medication score [1 year]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Roxall Medizin	Hamburg	Germany