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The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.
randomized, double-blind, active-controlled, multicenter, phase 3 trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test arm | Experimental | Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg |
|
| Comparator arm I | Active Comparator | Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg |
|
| Comparator arm II | Active Comparator | Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast + Levocetirizine | Drug | Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daytime Nasal Symptom Score | Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment | Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment | 4 weeks |
| Mean Composite Symptom Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyungmi PARK, PhD | Hanmi Pharmaceutical Company Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
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| Levocetirizine | Drug | Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) |
|
|
| Montelukast | Drug | Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) |
|
|
Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment |
| 4 weeks |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| 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 |
|---|---|
| C093875 | montelukast |
| C472067 | levocetirizine |
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