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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.
Verified November 2015 by Roxall Medizin
Sponsor:
Roxall Medizin
Information provided by (Responsible Party):
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01013116
First received: November 11, 2009
Last updated: November 2, 2015
Last verified: November 2015
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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 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 |
Further study details as provided by Roxall Medizin:
Primary Outcome Measures:
- Symptom and medication score [ Time Frame: 1 year ]
Secondary Outcome Measures:
- Safety of the treatment [ Time Frame: 1 year ]
- Documentation of adverse events [ Time Frame: 1 year ]
- Clinical global improvement [ Time Frame: 1 year ]
- Quality of Life Questionnaire [ Time Frame: 1 year ]
| 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
|
Eligibility| 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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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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017