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
Information provided by (Responsible Party):
Roxall Medizin
ClinicalTrials.gov Identifier:
First received: November 11, 2009
Last updated: November 2, 2015
Last verified: November 2015
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
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: 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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Contact: Roxall Medizin +49408972520

Madrid, Spain
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: November 2, 2015
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 30, 2015