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| ID | Type | Description | Link |
|---|---|---|---|
| 9427-B2171-22C (CR Number) | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Kingston Health Sciences Centre | OTHER |
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Finding out how fast azelastine nasal spray works in subjects with hay fever.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelastine and placebo | Drug | One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline | Up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy | Effect over 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston | Ontario | K7L 2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29371864 | Derived | Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018. |
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| Loratadine and Placebo | Drug | One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms. |
|
| Cetirizine and Placebo | Drug | One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms. |
|
| Placebo and Placebo (spray and Tablet) | Drug | One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms. |
|
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C020976 | azelastine |
| D017336 | Loratadine |
| D017332 | Cetirizine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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