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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022113-25 | EudraCT Number |
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RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV568 treatment group | Experimental |
| |
| Placebo treatment group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV568 | Drug | RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total nasal symptom score (TNSS) | Nasal congestion, rhinorrhoea, nasal itching and sneezing will be scored on a categorical scale from 0 to 3. Individual scores will be summed to produce the TNSS | 2 day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Eye symptom score | Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3 | 2 day treatment period |
| Global symptom score | Sum of symptom scores; TNSS, Eye symptom score, Other symptom score,(comprising congestion, rhinorrhoea, nasal itching, sneezing, watery eyes, itchy eyes, red eyes, cough, itchy throat and itchy ears) will be scored categorically from 0 to 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Dr Friedrich Horak, MD | Institute for Allergy Research - Vienna Challenge Chamber | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Allergy Research, Vienna Challenge Chamber | Vienna | 1150 | Austria |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Drug | Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2 |
|
| 2 day treatment period |
| Nasal airflow resistance | 2 day treatment period |
| Safety parameters | Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment | 3 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |