To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic idiopathic urticaria: a randomized, double-blind, comparative, parallel group study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the following aims and objectives:
研究概览
简要总结
STUDY RATIONALE
H1 receptor antagonists are main stay of therapy for allergic diseases such as chronic idiopathic urticaria, allergic rhinitis, allergic conjunctivitis. These diseases are evoked by common pathological mechanism characterized by release of histamine and other inflammatory mediators. First generation H1 receptor antagonists like chlorpheneramine , diphenhydramine hydroxyzine and promethazine have not been considered ideal antihistaminics as they cause significant sedation and may produce some anticholinergic side effects which may be harmful to the patients. Second generation antihistaminics like cetirizine, levocetirizine, loratadine, fexofenadine, astemizole, terfenadine, mizolastine, ebastine, rupatadine, olopatadine etc have higher H1 selectivity. Therefore, they do not have anticholinergic side effects. These groups of drugs also have no CNS depressant activity. They also have some additional antiallergic activity by inhibiting late phase of allergic reaction by acting on leukotrines or by antiplatelet activating factor. [2]
Rupatadine is a novel selective long acting histamine H1 receptor inverse agonist (H1 antihistamine), which is currently approved as a once daily dose of 10milligram, for the treatment of allergic rhinitis and chronic idiopathic urticaria. Rupatadine has shown to have a higher affinity for the H1 receptor than fexofenadine and levocetirizine. It has both antihistaminic and anti-platelet activation factor (PAF) property. It may produce side effects like headache, sleepiness, fatigue, dry mouth, dyspepsia . [3]
Oloaptadine is a selective histamine H1 receptor-antagonist having inhibitory effects on the release of inflammatory lipid mediators such as leukotrienes, thromboxane, platelet-activating factor (PAF), etc, from human polymorphonuclear leucocytes and eosinophils. It also inhibits the tachykininergic contraction in the bronchi of the allergen model by prejuntional inhibition of peripheral sensory nerves. [4] Olopatadine is recently approved for the treatment of chronic idiopathic urticaria. It has additional advantage over other drugs that it inhibits the release of inflammatory lipid mediators like leukotrienes, thromboxane, platelet-activating factor (PAF).
In recent years, treatment of CIU has changed from levocetirizine to rupatadine and olopatadine. Current treatment of CIU comprises of either these drugs used for 1 to 3 months duration. Research has been attempted to find the best drug for CIU focusing on efficacy and safety data. Indian population being commonly affected by CIU, patients has poor affordability for the most efficacious drug for treatment of CIU. Hence, it was decided to study and compare two drugs- the currently considered medicine of choice rupatadine, and the most recently introduced olopatadine in the local population of Central India. Therefore, aim of present study is to provide better and improved treatment option for CIU based on cost effectiveness, efficacy, and safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria 1) Those who were willing to participate in the study and comply with its procedures by signing a written informed consent.
- •Patients from Out-Patient Department (OPD) of dermatology between age group of 18 to 65 years of either sex.
- •History of urticarial wheal and/or angioedema for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study.
- •Mean total symptom score (24 hour reflective) ≥ 3 at screening.
- •This includes 1-5 number of wheals (score ≥ 1); at least a moderate severity of pruritus (score≥2).
- •Patients who were on any antihistamines except rupatidine and olopatadine were also included in the trail only after giving washout period of 7 days, irrespective of doses of the previous drugs.
- •Those who understood and agreed to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
排除标准
- •Exclusion criteria 1) History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids.
- •Subjects with acute spontaneous urticaria or all physical and other subtypes of urticaria like aquagenic, cholinergic, contact and exercise induced urticaria 3) Had been unresponsive to antihistamine treatment in the past.
- •History of allergies to study medication or unable to tolerate antihistamines.
- •Use of study drug in the last 7 days prior to baseline and not willing to take washout period.
- •Pregnant female, nursing mothers.
- •Subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease.
结局指标
主要结局
the following aims and objectives:
时间窗: Six weeks study..patient will be followed at one, three and six week.
1) To compare efficacy of rupatadine and olopatadine in patients of CsU.
时间窗: Six weeks study..patient will be followed at one, three and six week.
A) Primary end point:
时间窗: Six weeks study..patient will be followed at one, three and six week.
To compare difference in mean total symptom score (MTSS) at baseline and six week.B) Secondary endpoint:
时间窗: Six weeks study..patient will be followed at one, three and six week.
a) To observe difference in average mean number of wheals (MNW), mean pruritus scale (MPS) and MTSS from baseline to end of one, three and six week.
时间窗: Six weeks study..patient will be followed at one, three and six week.
次要结局
- Secondary end point(a) Average change from baseline to end of 6 weeks treatment period in)