Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

This study is currently recruiting participants.

Verified November 2009 by Roxall Medizin

First Received on November 11, 2009. Last Updated on July 13, 2011 History of Changes

Sponsor:	Roxall Medizin
Information provided by:	Roxall Medizin
ClinicalTrials.gov Identifier:	NCT01013116

Purpose

The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.

Condition	Intervention	Phase
Allergic Rhinitis	Biological: modified allergen extract of house dust mites Biological: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-blind Placebo-controlled Trial to Evaluate Efficacy and Safety of Specific Subcutaneous Immunotherapy in Patients With Perennial Allergic Rhinitis Due to House Dust Mites

Further study details as provided by Roxall Medizin:

Primary Outcome Measures:

Symptom and medication score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety of the treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Documentation of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Clinical global improvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Quality of Life Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	November 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: modified allergen extract of house dust mites	Biological: modified allergen extract of house dust mites subcutaneous injections
Placebo Comparator: Placebo	Biological: placebo subcutaneous injections

Eligibility

Criteria

Inclusion Criteria:

Positive history of perennial allergic rhinitis due to house dust mites
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 mite 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013116

Contacts

Contact: Roxall Medizin

+49408972520

Locations

Sponsors and Collaborators

Roxall Medizin

More Information

No publications provided

Responsible Party:	Roxall Medizin
ClinicalTrials.gov Identifier:	NCT01013116 History of Changes
Other Study ID Numbers:	SBC-2009-002B
Study First Received:	November 11, 2009
Last Updated:	July 13, 2011
Health Authority:	Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012