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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Roxall Medizin.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014325
First Posted: November 16, 2009
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxall Medizin
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Safety of sublingual application [ Time Frame: 1 year ]
  • Protocol of adverse events [ Time Frame: 1 year ]
  • Quality of Life Questionnaire [ Time Frame: 1 year ]
  • Evaluation of patients' related clinical global improvement [ Time Frame: 1 year ]

Estimated Enrollment: 130
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014325


Contacts
Contact: Roxall Medizin +49408972520

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

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01014325     History of Changes
Other Study ID Numbers: SLG-2009-006B
First Submitted: November 11, 2009
First Posted: November 16, 2009
Last Update Posted: November 3, 2015
Last Verified: November 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