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

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ClinicalTrials.gov Identifier: NCT01013116
Recruitment Status : Unknown
Verified November 2015 by Roxall Medizin.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2009
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Roxall Medizin

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Biological: modified allergen extract of house dust mites Biological: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Symptom and medication score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Safety of the treatment [ Time Frame: 1 year ]
  2. Documentation of adverse events [ Time Frame: 1 year ]
  3. Clinical global improvement [ Time Frame: 1 year ]
  4. Quality of Life Questionnaire [ Time Frame: 1 year ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01013116


Contacts
Contact: Roxall Medizin +49408972520

Locations
Spain
Recruiting
Madrid, Spain
Sponsors and Collaborators
Roxall Medizin
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01013116     History of Changes
Other Study ID Numbers: SBC-2009-002B
First Posted: November 13, 2009    Key Record Dates
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