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Trial record 65 of 66 for:    Levocetirizine

To Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria

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ClinicalTrials.gov Identifier: NCT03250143
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Davinder Parsad, Postgraduate Institute of Medical Education and Research

Brief Summary:
Fifty six patients of CRU attending the urticaria clinic in the department of Dermatology, Venereology and Leprology at the Post Graduate Institute of Medical Education and Research, Chandigarh will be recruited in the study calculated by using equivalence analysis assuming power of 90%, significance level of 5% and standard deviation of 1 and adjusting 5% of expected drop-outs after taking written informed consent. This study is undertaken with an intention to treat the patients of chronic refractory urticaria completely. Patients will be randomized into two groups A and B using computer generated random number tables, group A will receive Cyclosporine and group B will receive Azathioprine; wherein, 28 random single and double-digit numbers from 1-56 will be selected before recruitment, and patients coming on these numbers will be randomized in a particular group. Random number generation, recruitment and randomization, were all done by the same investigator..

Condition or disease Intervention/treatment Phase
Chronic Refractory Urticaria Drug: cyclosporine vs azathioprine Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study to Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Active Comparator: group A
Oral cyclosporine 3mg/kg/day (200mg/day) will be started.If there is no improvement in 1 week then escalating the dose maximum upto 5mg/kg/day.
Drug: cyclosporine vs azathioprine
Group A cyclosporine 3mg/kg/day and group B azathioprine 1mg/kg/day
Other Name: levocetrizine

Active Comparator: group B
Oral azathioprine will be started at 1mg/kg/day.If there is no improvement in 1 week then escalating the dose maximum upto 100mg/day
Drug: cyclosporine vs azathioprine
Group A cyclosporine 3mg/kg/day and group B azathioprine 1mg/kg/day
Other Name: levocetrizine




Primary Outcome Measures :
  1. Change in UAS7(urticaria activity score) ranging between( numerical value) 0-6 average of 7 days( primary end point) [ Time Frame: 12 weeks ]
    Change in urticaria activity score (UAS7) ranging between 0-6 in average of 7 days i.e decrease more than 75% from baseline to week 12 (at end of treatment) within group A and B and comparison between corresponding groups.


Secondary Outcome Measures :
  1. Change in OSS(outcome scoring scale) from baseline to 12 weeks ranging between( numerical value) 0-5 ( secondary end point) [ Time Frame: 12 weeks ]
    a. Change in outcome scoring scale (OSS) ranging between 0-5 from baseline to week 12 within group A and B.

  2. Change in ASST, APST( in milimeters),( numerical value) from baseline to week 12 within group A and B [ Time Frame: 12 weeks ]
    Change in autologous serum and plasma skin tests measured in milimeters and considering its positivity and negativity within group A and B.

  3. Change in S.IgE levels ( in UI/ml) from baseline to week 12 within group A and B [ Time Frame: 12 weeks ]
    Change in serum IgE levels (in UI/ml) noted at baseline to week 12 within group A and B.

  4. Change in both UAS7 and OSS ( secondary end point. [ Time Frame: 24 weeks ]
    Change in UAS7 and OSS from baseline to week 24 (end of follow-up) within group A and B.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Available definition for chronic refractory urticaria (CRU) is chronic spontaneous urticaria, with disease duration of at least 6 months or above, which is not controlled with four fold increased dosage of antihistamines (as per EAACI guidelines) figure1, given for at least three consecutive months and requiring repeated courses of oral corticosteroids.

Age ≥ 18 years.

Exclusion Criteria:

  • Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis.
  • Urticaria< 6 weeks.
  • Age <18 years.
  • Physical and pressure urticaria.
  • Urticarial vasculitits.
  • Pregnant and lactating patients.
  • Cataract, hepatic or renal diseases, severe infections, poorly controlled hypertension
  • Concomitant intake of drugs like nephrotoxic drugs (gentamycin, vancomycin, amphotericin-B, indomethacin, diclofenac, H2 antihistamines like ranitidine, cimetidine, phenobarbitone, rifampicin, allupurinol, febuxostat).
  • History suggestive of allergy to azathioprine , cyclosporine.
  • Absolute contraindications69 of azathioprine are severe infections, severly impaired hepatic or bone marrow function, pancreatitis, live vaccines, pregnancy and lactation.
  • Patients with chronic kidney disease, uncontrolled hypertension, renal insufficiency, uncontrolled infections, cutaneous T-cell lymphoma, including mycosis fungoides, should not be given Cyclosporine70.
  • Patients who are planning pregnancy.

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 ClinicalTrials.gov identifier (NCT number): NCT03250143


Locations
India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: Davinder Parsad, DParsad(professor), Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03250143     History of Changes
Other Study ID Numbers: INT/IEC/2017/609
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Azathioprine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents