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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 in Adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine + Prednisolone | Experimental | The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication. Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication. Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication. |
|
| Dexchlorpheniramine + Betamethasone | Active Comparator | The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine + Prednisolone | Drug | 1 tablet 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMA - Instituto de Pesquisa ClÃnica e Medicina Avançada | São Paulo | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 24, 2015 | |
| Reset | Sep 23, 2015 | |
| Release | Mar 30, 2021 |
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| Dexchlorpheniramine + Betamethasone |
| Drug |
1 tablet 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 24, 2015 | Sep 23, 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 |
|---|---|
| C121345 | desloratadine |
| D011239 | Prednisolone |
| C018904 | dexchlorpheniramine |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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