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| ID | Type | Description | Link |
|---|---|---|---|
| CNPq | Other Grant/Funding Number | CNPq480010/2007-2 |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.
Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mite allergen drop | Active Comparator | Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo. |
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| mite plus bacterial extracts | Active Comparator | Vaccine constituted with mite and bacterial extracts will be compared to placebo. |
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| Placebo | Placebo Comparator | Placebo will be constituted by the same solution used to make dilution of the allergen extracts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mite, Mite and Bacterial or Placebo | Biological | All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Symptom and Medication Scores at 12 months | For clinical evaluation will be used a questionnaire determining the symptom and medication scores. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Specific Antibody Levels. | Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens. | Baseline, 12 months and 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto A Taketomi, MD, PhD | Federal University of Uberlandia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Rhinitis Control Program | Itumbiara | Goiás | 75503-520 | Brazil |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2012 | Feb 8, 2012 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |