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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003680-39 | EudraCT Number |
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To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.
The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pangramin Plus D. pteronyssinus | Active Comparator | Pangramin Plus D. pteronyssinus 100% for subcutaneous injection |
|
| Placebo | Placebo Comparator | Placebo for subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pangramin Plus D. pteronyssinus | Biological | Subcutaneous immunotherapy with Dermatophagoides pteronyssinus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months | Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point). | Baseline, month 1,3,6,12,18, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months | Baseline, month 1,3,6,12,18, and 24 | |
| Change from Baseline response to intradermal test at 1,3,6,12 and 24 months | Baseline, month 1,3,6,12,18, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Blanca, MD, PhD | Allergy Unit, Regional University Hospital of Malaga, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Carlos Haya | Málaga | Malaga | 29009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27008542 | Derived | Rondon C, Campo P, Salas M, Aranda A, Molina A, Gonzalez M, Galindo L, Mayorga C, Torres MJ, Blanca M. Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial. Allergy. 2016 Jul;71(7):1057-61. doi: 10.1111/all.12889. Epub 2016 Apr 13. |
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| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D039741 | Antigens, Dermatophagoides |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Placebo | Biological | Placebo for subcutaneous injection |
|
| Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months | Baseline, month 1,3,6,12,18, and 24 |
| Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months | Baseline, month 1,3,6,12,18 and 24 |
| Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months | Baseline, month 1,3,6,12,18 and 24 |
| Adverse event | 2 years |
| D012140 |
| Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |