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

Allergic Rhinitis Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01012752
• Other study ID #: SBC-2009-003B
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: November 2, 2015
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2015
• Source: Roxall Medizin
• Contact: Roxall Medizin
• Phone: +49408972520
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis

Intervention

Biological:
• modified allergen extract
subcutaneous injections
• Placebo
subcutaneous injections

Locations

Country	Name	City	State
n/a

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