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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Vasomotor Rhinitis

Treatments: Drug: Pseudoephedrine / Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01509209

HM-LCT-301

Details and patient eligibility

About

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

Full description

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

Enrollment: 137 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Pseudoephedrine / Levocetirizine

Cossac L

Experimental group

Description:

Pseudoephedrine 120mg + Levocetirizine 2.5mg

Treatment:

Drug: Pseudoephedrine / Levocetirizine