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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Roxall Medizin.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01013116
First received: November 11, 2009
Last updated: July 13, 2011
Last verified: November 2009
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
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
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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

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

ClinicalTrials.gov processed this record on March 03, 2015