Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

Phase 3CompletedNCT01509209

Hanmi Pharmaceutical Company Limited137 enrolled

Overview

The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

randomized, double-blind, placebo-controlled, phase 3

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

137

Conditions

Vasomotor Rhinitis

Interventions

Pseudoephedrine / LevocetirizineDRUG

tablet, BID everyday

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of vasomotor rhinitis Exclusion Criteria: * Significant concomitant medical condition * Use corticosteroids or other allergy medications during the study * Considered by investigator as not appropriate to participate in the clinical study with othe reason

Locations (1)

ear, nose and throat, Boramae Hospital

Dongjak, Seoul, South Korea

Outcomes

Primary Outcomes

TVRSS(Total Vasomotor Rhinitis Symptom Score)

the change from baseline in TVRSS

Time frame: 2week

Secondary Outcomes

TVRSS, VRSS

* the change from baseline in TVRSS during 1st week and 2nd week * the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week

Time frame: 1week or 2 week

Data from ClinicalTrials.gov

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