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Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria (LEVURE PLUS)

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.
 
ClinicalTrials.gov Identifier: NCT02372604
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE February 20, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
UAS7≤6 (Proportion of patients with a UAS7≤6). [ Time Frame: After 5 weeks of treatment (plus or minus 2 days; week 5- visit 3). ]
The UAS7 (Urticaria activity score) is calculated as the sum of UAS over 1 week.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • Score of pruritus -> Assessment of the weekly score of pruritus [ Time Frame: 5 weeks -> After 5 weeks of treatment (visit 3). ]
  • Complete remission of urticaria at week 5 [ Time Frame: 5 weeks -> After 5 weeks of treatment (visit 3). ]
    Proportion of patients in complete remission of urticaria after 5 weeks of treatment (UAS7 = 0).
  • Complete remission of urticaria [ Time Frame: 10 weeks -> After 10 weeks of treatment (visit 4). ]
    Proportion of patients in complete remission of urticaria after 10 weeks of treatment (UAS7 =0).
  • Quality of life -> Evolution of the quality of life (between week 0, week 5 and week 10). [ Time Frame: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10). ]
    The quality of the life is evaluated by two questionnaires, the DLQI (DERMATOLOGY LIFE QUALITY INDEX) and the CU-Q2oL (Chronic Urticaria Quality of Life Questionnaire). The DLQI and CU-Q2oL scores are calculated by summing the score of each question.
  • Tolerance of the treatment -> assessment of the tolerance of the H1-antihistamine in up 4 times conventional doses compared to the regulatory dosage of H1-antihistamine. [ Time Frame: week 0, week 5 and week 10 -> At the study beginning (week 0), at the week 5 of the study and finally at the end of the study (week 10). ]
    The tolerance is evaluated by one questionnaire, the Epworth sleepiness scale (ESS). The ESS is an effective instrument used to measure average daytime vigilance and sleepiness. It is calculated by summing the score of each question.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria
Official Title  ICMJE Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage
Brief Summary

Chronic Spontaneous Urticaria (CSU), defined by the persistence of daily or almost daily urticaria over 6 weeks, affects 0.5% to 1% of the general population. In more than half of the cases, it lasts more than 2 years. It can dramatically alter the quality of life, in particular sleep, and generates numerous consultations and hospitalizations, with an average annual cost per patient close to 2000 euros in Europe. The treatment is based on the validated 2nd generation anti-H1 antihistamines dosage of one tablet per day whose effectiveness is satisfactory, however about half the time. In cases of severe CSU refractory to treatment with anti-H1 licensed dosage, few therapeutic alternatives exist, still off-label: the monketulast, an anti-leukotriene, ciclosporine or methotrexate, as immunosuppressants. Various studies have shown the important benefit of an expensive anti-IgE biological: the omaluzimab. Several open studies have also suggested superior efficacy and good tolerability of anti-H1 in higher dosage (double, triple or quadruple) including levocetirizine.

The off-label use of these high dosages of anti-H1 is growing very rapidly in France, tending to replace the use of anti-H1 first generation or substitution to another 2nd generation anti-H1 recommended by the French Society of Dermatology.

This study, under the aegis of the Urticaria Group of the French Society of Dermatology, intends to compare the efficacy of levocetirizine 4 tablets/day versus 1 tablet/day in the treatment of CSU resistant to anti-H1 licensed dosage.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Spontaneous Urticaria
Intervention  ICMJE
  • Drug: Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.

    Week 1 to week 5, every day : - the morning : 5 mg of levocetirizine (capsule)

    • the evening : placebo capsule

    Week 6 to week 10, every day : - the morning : 10 mg of levocetirizine (capsule)

    • the evening : 10 mg of levocetirizine (capsule))
  • Drug: Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.

    Week 1 to week 5, every day : - the morning : 10 mg of levocetirizine (tablet)

    • the evening : 10 mg of levocetirizine(tablet)

    Week 6 to week 10, every day : - the morning : 5 mg of levocetirizine (tablet)

    • the evening : placebo tablet
Study Arms  ICMJE
  • Active Comparator: Group1 : Regulatory dosage

    In a first time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 2 and 3).

    In a second time,and after primary endpoint assessment, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 3 and 4).

    Intervention: Drug: Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.
  • Experimental: Group 2 : fourfold dosage

    In a first time, every day, one tablet of 10 mg of levocetirizine is taken the morning and a second tablet of 10 mg of levocetirizine is taken the evening, during 5 weeks (between visit 2 and 3).

    In a second time, every day, one tablet of 5 mg of levocetirizine is taken the morning and a second tablet of placebo is taken the evening, during 5 weeks (between visit 3 and 4).

    Intervention: Drug: Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
224
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be ≥18 years of age at screening.
  • Chronic spontaneous urticaria already treated with anti-H1 for at least two months without sufficient efficacy.
  • Urticaria Activity Score (UAS7) >12 at the randomization visit (visit 2).
  • For female :

    • Of childbearing potential: female must use an acceptable method of contraception during the period of 1 month before the inclusion to 1 month after the last study visit;
    • Of non-childbearing potential: e.g. postmenopausal (absence of menstrual bleeding for 1 years), or having had a hysterectomy or bilateral ovariectomy or tubal ligation.
  • Patient agrees not to take other treatments than those provided in the study.
  • Willingness and ability to comply with the protocol requirements.
  • Written informed consent given prior to any study-related procedure.
  • Subject affiliated to the National Social Security System.

Exclusion Criteria:

  • Pregnancy, breastfeeding or planned pregnancy during the study.
  • Inducible urticaria (except immediate dermographism associated with CSU)
  • Differential diagnosis of CSU (urticarial vasculitis).
  • Known hypersensitivity to antihistamine.
  • Known hypersensitivity to one of the product components, to hydroxyzine or to piperazine derivative.
  • Sleepiness disorders or with Epworth sleepiness scale >15.
  • Treatment with systemic corticosteroids within the month before the screening visit.
  • Treatment with montelukast within the week before the screening visit.
  • Treatment with H2-antihistamine within the week before the screening visit.
  • Treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil …) within the month before the screening visit.
  • Known congenital galactosemia, glucose and galactose malabsorption, lactase deficiency, or lactose and fructose intolerance.
  • Swallowing disorders.
  • Liver dysfunction with transaminase greater than twice the normal value.
  • Renal failure with creatinine clearance <50mL/min (calculated by MDRD formula).
  • Regular or excessive alcohol consumption.
  • Unstabilized chronic disease under treatment.
  • Subject protected by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated).
  • Subject with any additional condition that, in the opinion of the investigator, may interfere with the study assessment or put the subject at risk.
  • Linguistic or mentally incapacity to sign the consent form.
  • Subject in an exclusion period from a previous study or who is participating in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372604
Other Study ID Numbers  ICMJE 2014.849
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frédéric BERARD, Professor Service d'Allergologie et Immunologie Clinique - Centre Hospitalier Universitaire Lyon Sud
PRS Account Hospices Civils de Lyon
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP