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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified November 2015 by Roxall Medizin

Sponsor:

Information provided by (Responsible Party):

Roxall Medizin

ClinicalTrials.gov Identifier:

NCT01013116

First received: November 11, 2009

Last updated: November 2, 2015

Last verified: November 2015

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:

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


Estimated Enrollment:	120
Study Start Date:	April 2016
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Roxall Medizin	+49408972520

Locations


Spain
	Recruiting
Madrid, Spain

Sponsors and Collaborators

Roxall Medizin

More Information


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:	November 2, 2015

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections	Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on May 24, 2017

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