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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509209
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Vasomotor Rhinitis Drug: Pseudoephedrine / Levocetirizine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509209

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Korea, Republic of
ear, nose and throat, Boramae Hospital
Dongjak, Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01509209    
Other Study ID Numbers: HM-LCT-301
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013
Keywords provided by Hanmi Pharmaceutical Company Limited:
Additional relevant MeSH terms:
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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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents