Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01949051 | A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis | PHASE2 | COMPLETED | 78 | — | — | Oct 1, 2013 | Feb 4, 2014 | Jun 6, 2017 | 1 | Canada |
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
| Arm | Type | Description |
|---|---|---|
| Levocabastine Arm | EXPERIMENTAL | Subjects will be assigned to one of six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) in accordance with the randomisation schedule. A = Two, 50 microgram (mcg) sprays per nostril of levocabastine QD in the morning. Total dose of 200 mcg. Two, 0 mcg sprays from placebo to match vehicle in the evening; B = Two, 50 mcg sprays per nostril of levocabastine BID in the morning and evening. Total dose of 400 mcg; C = Two, 0 mcg sprays per nostril from placebo vehicle in morning and evenings. |
| Name | Type | Description |
|---|---|---|
| Levocabastine | DRUG | Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension |
| Placebo | DRUG | Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension |
Inclusion Criteria: * Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal or perennial rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities. * Subjects have a TNSS score of \>=6 at the baseline scr...