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

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  Not yet recruiting
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01014325
First received: November 11, 2009
Last updated: July 13, 2011
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Biological: Allergen extract
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: Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

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 sublingual application [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Protocol of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evaluation of patients' related clinical global improvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allergen extract Biological: Allergen extract
sublingual application
Placebo Comparator: Placebo Biological: Placebo
sublingual application

  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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014325

Contacts
Contact: Roxall Medizin +49408972520

Locations
Spain
Not yet recruiting
Madrid, Spain
Sponsors and Collaborators
Roxall Medizin
  More Information

No publications provided

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01014325     History of Changes
Other Study ID Numbers: SLG-2009-006B
Study First Received: November 11, 2009
Last Updated: July 13, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 23, 2013