A Randomised Study to Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in UAS7(urticaria activity score) ranging between( numerical value) 0-6 average of 7 days( primary end point)
研究概览
简要总结
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..
详细描述
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), given for at least three consecutive months and requiring repeated courses of oral corticosteroids. There is no strict number of oral corticosteroids intake courses before the patient can be labeled as chronic refractory urticaria.
Study end- points
- Primary end-point :
Change in urticaria activity score (UAS7) 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. 2. Secondary end-points :
- Change in outcome scoring scale (OSS) from baseline to week 12 within group A and B.
- Change in UAS7 and OSS from baseline to week 24 (end of follow-up) within group A and B.
- Change in ASST, APST, IgE levels from baseline to week 12 within group A and B.
- Comparison for the above mentioned parameters between group A and B. Treatment sessions will be for three months, daily oral cyclosporine and daily oral azathioprine and after completion, patients will be additionally followed for three more months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 Cyclosporine
- •Patients who are planning pregnancy.
研究组 & 干预措施
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.
干预措施: cyclosporine vs azathioprine (Drug)
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
干预措施: cyclosporine vs azathioprine (Drug)
结局指标
主要结局
Change in UAS7(urticaria activity score) ranging between( numerical value) 0-6 average of 7 days( primary end point)
时间窗: 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.
次要结局
- Change in ASST, APST( in milimeters),( numerical value) from baseline to week 12 within group A and B(12 weeks)
- Change in S.IgE levels ( in UI/ml) from baseline to week 12 within group A and B(12 weeks)
- Change in both UAS7 and OSS ( secondary end point.(24 weeks)
- Change in OSS(outcome scoring scale) from baseline to 12 weeks ranging between( numerical value) 0-5 ( secondary end point)(12 weeks)
研究者
Davinder Parsad
DParsad(professor)
Post Graduate Institute of Medical Education and Research, Chandigarh