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

This study has been completed.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited Identifier:
First received: January 10, 2012
Last updated: May 22, 2013
Last verified: May 2013
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Condition Intervention Phase
Vasomotor Rhinitis
Drug: Pseudoephedrine / Levocetirizine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • TVRSS(Total Vasomotor Rhinitis Symptom Score) [ Time Frame: 2week ]
    the change from baseline in TVRSS

Secondary Outcome Measures:
  • TVRSS, VRSS [ Time Frame: 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

Enrollment: 137
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L
Experimental: Cossac L
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L

Detailed Description:
randomized, double-blind, placebo-controlled, phase 3

Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01509209

Korea, Republic of
ear, nose and throat, Boramae Hospital
Dongjak, Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01509209     History of Changes
Other Study ID Numbers: HM-LCT-301
Study First Received: January 10, 2012
Last Updated: May 22, 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents processed this record on May 25, 2017