Trial record 3 of 66 for:    Levocetirizine

Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses (LevoHydroxy)

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: NCT01250652
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : July 17, 2013
UCB Pharma
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

Brief Summary:
Allen Kaplan is a prominent American allergist with the reputation of leader in the field of chronic urticaria. He advocates treatment with first generation hydroxyzine, which he considers at least as effective as modern second generation H1-blockers in suppressing the symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He further speculates that hydroxyzine may have the advantage to better suppress itch and improve nighttime sleep. This has prompted many practitioners around the world to believe that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to patients. At the same time European guidelines indicate modern second generation H1-blockers in higher than conventional doses as drugs of choice for such cases. However, there is no evidence from clinical trials addressing this controversy. The investigators' previous studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to treat urticaria by reducing lesions and itch, improving quality of life and night time sleep, while not causing day time somnolence. First generation H1-receptor antagonists and hydroxyzine among them are known to penetrate the blood / brain barrier and to cause sedation. The question stays whether this sedation is beneficial to the subjects with chronic urticaria at night, whether it has any hang-over unwanted effects the following day and whether this has any influence on the overall urticaria-specific quality of life.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Drug: Levocetirizine Drug: Levocetirizine plus Hydroxyzine Phase 4

Detailed Description:

Study design:

The study will involve two distinct parts (flow chart):

  1. In-hospital assessment of effectiveness and tolerability of 10 & 20 mg levocetirizine vs. 100 & 200 mg hydroxyzine in subjects to be weaned off corticosteroid treatment.
  2. Subsequent ambulatory treatment of the same patients with 20 mg levocetirizine alone and 15 mg levocetirizine + 50 hydroxyzine at night

Protocol description Patients with chronic urticaria treated with systemic steroids are traditionally admitted to the Clinic of Allergy and Asthma in Sofia to try to wean them off this class of drugs. Hospitalized patients will be invited to take part in the study and will sign an informed consent. They will be assessed by standard questionnaire and by objective assessment of the urticarial lesions, QoLQ will be filled in, discomfort due to urticaria, day time somnolence and night time sleep quality will be assessed on a visual analogue scale. Systemic steroids will be withheld and patients would be given 10 mg levocetirizine on Days 1 & 2; after a new assessment of quality of night time sleep and day time somnolence, 100 mg hydroxyzine will be given on Days 3 & 4. The cycle will be repeated on Days 5 & 6 and Days 7 & 8 with 20 mg levocetirizine and 200 hydroxyzine respectively. At this point patients will be discharged and randomized to two treatment arms: levocetirizine 20 mg per day and levocetirizine 15 mg + hydroxyzine 50 mg as evening dose for 5 days. Diaries will be given to patients for assessment of daily SS, day time somnolence score, quality of night time sleep, facial tissue swelling, rescue medication with oral prednisolone, adverse events, intake of any other medications. After 5 days the patients from arm 1 and 2 will be crossed over to the alternative treatment. QoLQ questionnaire will be filled out at onset, at cross over (day 5) and at the end of the 10 day treatment period. On completion of the study subjects will be asked to state there preference for one treatment or the other.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 20 mg Levocetirizine and 15 mg Levocetirizine + 50 mg Bed-Time Hydroxyzine in Severe Chronic Urticaria in Adults: a Pilot, Randomized, Double-blind, Cross-over and Parallel, Active-controlled, Single-centre Study
Study Start Date : March 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Active Comparator: Levocetirizine
24 patients will received 20 mg Levocetirizine daily
Drug: Levocetirizine
20 mg levocetirizine for 5 days
Other Name: Xyzal

Experimental: Levocetirizine plus Hydroxyzine
24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
Drug: Levocetirizine plus Hydroxyzine
24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
Other Name: Xyzal plus Atarax

Primary Outcome Measures :
  1. Urticaria specific quality of life [ Time Frame: 1 year ]
    The primary objective of the study is to compare the effect on urticaria specific quality of life of two regimens: levocetirizine 20 mg per day (4x1 tablets) vs. levocetirizine 15 mg (3x1 tablets) + hydroxyzine 50 mg (2 tablets) before night time sleep.

Secondary Outcome Measures :
  1. Effect of the two regimens on urticaria symptoms [ Time Frame: 1 year ]
    To compare the effect of the two regimens on urticaria symptoms (number of wheals, pruritus severity

  2. Effect on night time sleep [ Time Frame: 1 year ]
    To compare the effect of the two regimens on the quality of night time sleep

  3. Effect on day time somnolence [ Time Frame: 1 year ]
    To compare the effect of the two regimens on the day time somnolence.

  4. The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG [ Time Frame: 1 year ]
    To document the effect of treatment with higher doses of levocetirizine or hydroxyzine on blood eosinophil numbers, Na+(sodium ion), K+(potassium ion), ALAT (Alanine transaminase), AST (Aspartate transaminase), ECG (Electrocardiogram)

  5. To assess adverse events [ Time Frame: 1 year ]
    To investigate safety by assessing the nature, incidence and severity of adverse events within the treatment groups

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 24 randomized patients of either sex,
  • ≥18 years of age.
  • Included patients should have at least a 6-week documented history of urticaria with intake of 15-30 mg Prednisolon.

Exclusion Criteria:

  • Patients with physically induced urticarias;
  • pregnancy and lactation;
  • any chronic disease requiring daily other drug treatment including, antihypertensives, antipsychotics and antidepressants;
  • other skin disease

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): NCT01250652

Medical University Sofia, Department of Allergology
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Association Asthma, Bulgaria
UCB Pharma
Principal Investigator: Todor A Popov, MD, PhD Professor of Allergology

Responsible Party: Prof. Todor Popov, Association Asthma, Bulgaria Identifier: NCT01250652     History of Changes
Other Study ID Numbers: 67LH13102010
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

Keywords provided by Prof. Todor Popov, Association Asthma, Bulgaria:
Chronic urticaria

Additional relevant MeSH terms:
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System 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
Dermatologic Agents