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The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine + Prednisolone | Experimental | Desloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3. |
|
| Dexchlorpheniramine + Betamethasone | Active Comparator | Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexchlorpheniramine + Betamethasone | Drug | Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score | The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirceu Solé, MD | Federal University of São Paulo | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2015 | |
| Reset | Sep 25, 2015 | |
| Release | Mar 30, 2021 |
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| Desloratadine + Prednisolone | Drug | Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day |
|
| Reset | Apr 23, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2015 | Sep 25, 2015 | |||
| Mar 30, 2021 | Apr 23, 2021 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C018904 | dexchlorpheniramine |
| D001623 | Betamethasone |
| C121345 | desloratadine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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