- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586091
Safety Study of Levocetirizine and Fexofenadine (LAWAF)
September 15, 2019 updated by: Martin Metz, Charite University, Berlin, Germany
Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal, Flare and Itch Response
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a randomized, double-blind, placebo-controlled study with intra-individual comparison of the histamine induced wheal and flare reaction.
In September 2009, Fexofenadine was approved as an antihistamine against allergies in Japan and it is currently used widely.
It has been approved in 120 countries, including the US, UK, France and Germany [11].
In Europe and the United States, fexofenadine is marketed at 120 mg once daily for allergic rhinitis and 180mg once daily for urticaria.
In Japan, fexofenadine is marketed at 60 mg twice daily for both conditions.
But is this dosage regimen as effective as levocetirizine, 5 mg once daily?
The above described study from Takahashi et al, comparing 60 mg twice daily versus cetirizine 10 mg once daily suggests that it is not [4].
The aim of the study is to compare the efficacy and consistency of action of levocetirizine 5 mg once daily with fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal, flare and itch response.
Furthermore, we would like to investigate whether a different between Japanese and Caucasian exists or not.
Each volunteer will receive the study medication at time point 0 and 12 hour later.
Skin Prick Test (SPT) will be performed in each volunteer using histamine (10 mg/ml), 15 minutes before drug admission (baseline) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours afterwards.
Volumetric optical scanning system and infrared camera will be used for objective evaluation of the wheal- and flare reduction.
Additionally, measurement of the erythema diameter with a transparent ruler will be performed.
The subjective intensity of itching will be assessed using a Visual Analogue Scale (VAS).
To relate the pharmacokinetics of the drugs to their pharmacodynamics, blood samples for assay of drug concentrations will be taken at baseline and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours later.
Subjects will undergo the same procedure on three separate occasions to receive each treatment option.
The options are: placebo at time 0 hours + placebo at 12 hours, Levocetirizine 5mg at time 0 hours + placebo at 12 hours or fexofenadine 60mg at time 0 hours + fexofenadine 60mg at 12 hours.
There will be a washout period of at least 6 days between the treatments.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- University of Berlin Charité, Department of Dermatology and Allergy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study
Exclusion Criteria:
- None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo per os at time 0 hours + placebo per os at 12 hours.
|
Other Names:
|
Active Comparator: Levocetirizin
Levocetirizin 5mg at time 0 and placebo per os at 12 hours
|
Other Names:
|
Active Comparator: Fexofenadine
Fexofenadine 60mg per os at time 0 hours + fexofenadine 60mg per os at 12 hours
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pruritus as Assessed by the VAS Score
Time Frame: up to 10 minutes after skin prick test performed 24 hours after drug administration
|
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size.
Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus.
The mean VAS for each 10 min was calculated and used as a primary end Point.
|
up to 10 minutes after skin prick test performed 24 hours after drug administration
|
Flaire Diameter (mm)
Time Frame: 24 hours per treatment
|
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.
|
24 hours per treatment
|
Wheal Volume (cm3)
Time Frame: 24 hours per treatment
|
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).
|
24 hours per treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marcus Maurer, MD, Charite Universitatsmedizin Berlin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 23, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 26, 2012
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
September 15, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Skin Diseases, Vascular
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Skin Manifestations
- Rhinitis
- Rhinitis, Allergic
- Pruritus
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Levocetirizine
- Fexofenadine
Other Study ID Numbers
- 2010-022747-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual participant data will not be available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
Glenmark Specialty S.A.CompletedSeasonal Allergic Rhinitis (SAR)United States
Clinical Trials on Placebo Oral Tablet
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
EicOsis Human Health Inc.RecruitingHealthy SubjectsNew Zealand
-
Harmony Biosciences, LLCActive, not recruitingMyotonic Dystrophy 1 | Excessive Daytime SleepinessUnited States, Canada
-
Syntrix Biosystems, Inc.National Institute on Drug Abuse (NIDA); DF/Net ResearchCompletedDiabetic Neuropathies | Neuropathic Pain | Pain, ChronicUnited States
-
University of OxfordNovo Nordisk A/SRecruitingDiabetes Mellitus, Type 2United Kingdom
-
Fulcrum TherapeuticsTerminated
-
EicOsis Human Health Inc.CompletedHealthy AdultsUnited States
-
The Mind Research NetworkTerminatedSmoking Cessation | Tobacco Use DisorderUnited States
-
Cara Therapeutics, Inc.CompletedChronic Kidney Diseases | PruritusUnited States
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis CChina