Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses
Information source: Association Asthma, Bulgaria
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Urticaria
Intervention: Levocetirizine (Drug); Levocetirizine plus Hydroxyzine (Drug)
Phase: Phase 4
Sponsored by: Association Asthma, Bulgaria
Official(s) and/or principal investigator(s):
Todor A Popov, MD, PhD, Principal Investigator, Affiliation: Professor of Allergology
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.
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Urticaria specific quality of life
Effect of the two regimens on urticaria symptoms
Effect on night time sleep
Effect on day time somnolence
The effect on blood eosinophil numbers, Na+, K+, ALAT, ASAT, ECG
To assess adverse events
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.
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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.
- Patients with physically induced urticarias;
- pregnancy and lactation;
- any chronic disease requiring daily other drug treatment including,
antihypertensives, antipsychotics and antidepressants;
- other skin disease
Locations and Contacts
Medical University Sofia, Department of Allergology, Sofia 1431, Bulgaria
Kaplan AP. Chronic urticaria: pathogenesis and treatment. J Allergy Clin Immunol. 2004 Sep;114(3):465-74; quiz 475. Review.
Kaplan AP. What the first 10,000 patients with chronic urticaria have taught me: a personal journey. J Allergy Clin Immunol. 2009 Mar;123(3):713-7. doi: 10.1016/j.jaci.2008.10.050. Epub 2008 Dec 10.
Staevska M, Popov TA, Kralimarkova T, Lazarova C, Kraeva S, Popova D, Church DS, Dimitrov V, Church MK. The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria. J Allergy Clin Immunol. 2010 Mar;125(3):676-82. doi: 10.1016/j.jaci.2009.11.047.
Starting date: March 2011
Last updated: July 15, 2013