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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis | Biological: modified allergen extract of house dust mites Biological: placebo | Phase 3 |
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 |
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
|
- Symptom and medication score [ Time Frame: 1 year ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Roxall Medizin | +49408972520 |
Spain | |
Recruiting | |
Madrid, Spain |
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 |