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

Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509209

Enrollment

137

Registered

2012-01-12

Start date

2011-05-31

Completion date

2013-04-30

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasomotor Rhinitis

Keywords

vasomotor, pseudoephedrine, levocetirizine

Brief summary

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

Detailed description

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

Interventions

DRUGPseudoephedrine / Levocetirizine

tablet, BID everyday

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
TVRSS(Total Vasomotor Rhinitis Symptom Score)	2week	the change from baseline in TVRSS

Secondary

Measure	Time frame	Description
TVRSS, VRSS	1week or 2 week	* 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026