Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Allergic Rhinitis Clinical Trial

Official title:

Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01014325
• Other study ID #: SLG-2009-006B
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: November 2, 2015
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: November 2015
• Source: Roxall Medizin
• Contact: Roxall Medizin
• Phone: +49408972520
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Positive history of perennial 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 with allergen extracts 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

Intervention

Biological:
• Allergen extract
sublingual application
• Placebo
sublingual application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medizin

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom and medication score		1 year	Yes
Secondary	Safety of sublingual application		1 year	Yes
Secondary	Protocol of adverse events		1 year	Yes
Secondary	Quality of Life Questionnaire		1 year	Yes
Secondary	Evaluation of patients' related clinical global improvement		1 year	Yes