Comparison of safety and usefulness of levocetrizine tablet and bepotastine tablet in patients suffering from hives for more than 6 weeks
- Conditions
- Chronic urticaria
- Registration Number
- CTRI/2018/05/013729
- Lead Sponsor
- Institutional
- Brief Summary
Chronic Urticaria (CU) is a common and distressingdermatoses where release of mast cell mediators cause inflammation andaccumulation and activation of other cells consisting of CD4+ andCD8+ T lymphocytes, eosinophils, basophils and neutrophils. Theprimary aim of treatment of CU is symptomatic relief and avoidance oftriggering factors. The impact of CU on quality of life is overwhelming, includingproblems in home management, personal care, recreation and social interaction,mobility, emotional factors, sleep, rest and work that can lead to socialisolation and altered emotional reactions.
In the search for newer modalities to supplement thepharmacotherapy for urticaria, Bepotastine, a second generation antihistaminewith added effect on suppression of eosinophil migration with fewer adverseeffects can be explored to reduce the burden of pills while maintaining a symptom-freeinterval. Furthermore, bepotastine doesnot interact with serotonin, muscarinic, benzodiazepine, andbeta-adrenergic receptor that would otherwise result in adverse reactions suchas dry mouth or sonmolence. This improved adverse effect profile can makebepotastine more tolerable to patients than the conventional antihistamines.
Thus the present study will be conducted with the objectiveof assessing and comparing the efficacy, safety and tolerability of Bepotastine with the standardantihistamine, Levocetrizine in chronic urticaria .
Thestudy will be carried out in the outpatient department (OPD) of Department ofDermatology, Bankura Sammilani Medical College, Bankura, a tertiary care centrein Eastern India. Patients of either sex, aged 18 yrs to 85 years, clinicallydiagnosed as CU will be recruited keeping in mind the inclusion and exclusioncriteria.
According to randomisation every patient will begiven either Levocetrizine 5 mg oncedaily or Bepotastine 10 mg twice daily at fortnightly interval for 3 months andthen will be followed up for another 3 months; total study period for eachpatient being 6 months. Seventy eligible patients will be randomized intoeither group A (receiving Bepotastine) or group B (receiving Levocetrizine)with allocation ratio 1:1 as per the randomization sequence. It isa single blind (Investigator-blind) controlled clinical trial. The dispensingand assessing physicians will be different. The assessing physician will bemade un-aware (blind) of the medication dispensed. Allocationconcealment will be done by sequentially numbered opaque sealed envelope(SNOSE) technique. Every patient will be followed up every two weekly for aperiod of 12weeks (End of treatment visit) and then monthly for 3 months withmedication taken at ‘on-demand’ basis (Test of cure visit).
Thenumber and size of wheals and degree of pruritus (grade 0, 1, 2, 3) atpresentation will be recorded in a standard case record form to assess the UrticariaSeverity Score (UAS) and other effectiveness parameters [Urticaria TotalSeverity Score (TSS), UAS7, Physicians’ and Patients’ global assessment ofdisease activity improvement (5 point Likert scale)]. Autologous serum skintest will be done on all patients. 0.05 ml of autologous serum will be injectedimmediately intra-dermally into the patients’ left flexor forearm 2 inchesbelow the antecubital crease and 0.05 ml sterile normal saline as negativecontrol into right forearm using 31G sterile disposable 1ml insulin syringe.The reading of the wheal will be taken after 30 minutes. This testdifferentiates autoreactive urticaria if positive and the response of thisspecific subgroup to treatment will be analysed.
There will be a provision for rescue medicationthroughout the study. Tablet prednisolone (0.5-1 mg/kg bd wt) may be used asrescue medication at the discretion of the treating physician. Baselineinvestigations will be done – Routine haemogram, random blood sugar, urea,creatinine, liver function tests (LFT) and will be repeated at 12 weeks. Spontaneouslyreported adverse effects and those elicited by the clinician at all follow upvisits will contribute to the safety parameter. Dermatological Life Quality Index (DLQI) will determine the quality oflife in participants at baseline, 12 weeks and study end at 24 weeks.
Data will be analysedusing Students’ T-test, ANOVA test for parametric data and Mann-Whitney’s test,Wilcoxon test or Friedman’s ANOVA with post hoc test for non-parametric data (asapplicable). The homogeneity of the population will be tested by variance ratiotest (F test) and categorical data will be analysed by using Chi-Square testand Fischer’s test as applicable. Subgroup analysis will be done forautoreactive urticaria (as per AST findings). The statistical software SPSS v10.0 & Medcalc® v 9.6.4.0 will be used for analysis & Graph-pad Prismwill be used for drawing the graphs. Modified intention to treat analysis willbe done with participants reporting for at least one follow-up. Safety analysiswill be done for all participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
Age 18 yrs to 85 years Near daily appearance of wheals for more than 6 weeks Urticaria Activity Score 7 (UAS 7) more than equal to 14 Informed consent obtained Willing for weekly follow-up and injections.
Pregnant and lactating women Immunosuppressed due to drug or disease Allergy to Levocetirizine Concomitant systemic illness requiring treatment Mental illness interfering with perception of urticarial symptoms Subjects working in night shifts or are likely to change the usual sleep/ wake cycle Patients driving automobiles Participation in any clinical trial within the last 3 months Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial Substance or alcohol abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Urticaria Activity Score 7 (UAS 7) 0 2 4 6 8 10 12 16 20 24 weeks
- Secondary Outcome Measures
Name Time Method Urticaria total severity score (TSS) 0 2 4 6 8 10 12 16 20 24 weeks Urticaria Activity Score (UAS) 0 2 4 6 8 10 12 16 20 24 weeks Changes in LFT Serum Urea Creatinine Routine Heamogram 0 and 12 weeks Patients’ global assessment of disease activity improvement (5 point Likert scale) 0 2 4 6 8 10 12 16 20 24 weeks Physicians’ global assessment of disease activity improvement (5 point Likert scale) 0 2 4 6 8 10 12 16 20 24 weeks Adverse events (Spontaneously reported and those elicited by clinician) 2 4 6 8 10 12 16 20 24 weeks
Trial Locations
- Locations (1)
Bankura Medical College
🇮🇳Bankura, WEST BENGAL, India
Bankura Medical College🇮🇳Bankura, WEST BENGAL, IndiaProf Nilay Kanti DasPrincipal investigator9433394148drdasnilay@gmail.com