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临床试验/CTRI/2018/05/014079
CTRI/2018/05/014079招募中不适用

To assess and compare the efficacy and safety of indacaterol acetate and glycopyrronium bromide with salmetrol and fluticasone in patients of bronchial asthma.

Aligarh Muslim University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Spirometry

研究概览

简要总结

BRONCHIALASTHMA:

Bronchial Asthmais a chronic inflammatory disorder of the airway in which many cells andcellular elements play a significant role in its causation.1Thechronic inflammation causes an increase in chest tightness and coughingparticularly at night or in early morning.2These episodes are usually associated with widespread but variable airflowobstruction that is often reversible either spontaneously or with treatment.

 Inhaled β2-agonistsare the most effective bronchodilatorsfor the prevention and relief ofbronchoconstriction associated with asthma, and therefore have an importantrole in managing asthma symptoms.8Long-acting β2-agonists ,such as salmeterol [3,9] and formoterol9, have 12-h durations of action, and their recommended use is in combinationwith inhaled corticosteroids (ICS) in patients with moderate or severepersistent asthma**.9**

 Selective β2-agonistswere developed to minimize mediated chronotropic effects that were associatedwith the non-selective agents such as isoprenaline. β2-receptors arealso present in myocardial tissue, and the occurrence of tachycardia andpalpitations has been associated with the use of older generation of selectiveβ2-agonists, especially at higher doses.Other dose-limiting β2-mediatedside effects include skeletal muscle tremor, hyperglycaemia and hypokalaemia.9Thus, an important propertyof newer β2-agonists, is to provide effective bronchodilation at adose that is not associated with these side effects and to have a wide safety.

INDACATEROL

Indacaterol is a novel medicine given once-a-dayin a dosage form of dry powder inhaler, “twisthaler deviceâ€, and fast-acting β2-agonistfor the treatment of asthma and chronic obstructive pulmonary disease (COPD).7Preclinicaldata suggests that, for a given degree of bronchodilator activity, indacaterolhas a greater cardiovascular safety margin than formoterol or salmeterol.10Indacaterolmaleate/acetate delivered by twisthaler in a dose of 150µg has been studied inhealthy volunteers,adult patients with COPD and asthma and found safe and welltolerated.10

                                       GLYCOPYRRONIUM

Glycopyrronium is anticholinergic drug.4It is a long-actingbronchodilator and works by relaxing the airways in the lungs over about 24hours, to make breathing easier. Glycopyrronium does not bring immediate relief; therefore it is not effective for sudden breathlessness .Glycopyrroniumis for inhalation only and must be used with Breezhaler. Common side effects ofglycopyrronium include dry mouth, insomnia, stomach cramps diarrhoea, vomiting,nose and throat irritation and muscle or bone or joint pain. Glycopyrronium is a maintenance treatmentfor people with controlled COPD (mild, moderate or severe).12 The effects from one inhaled dose of glycopyrronium 50 microgram (capsule)should last for 24hours.Glycopyrronium are avoided: if there is allergic manifestation to the patient .Then otheranticholinergic drug; for example, a reliever such as ipratropium can be used.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
12.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients of stable asthma diagnosed clinically and spirometrically with complaints of chest tightness and coughing particularly at night or in the early morning.
  • 2.All patients with documented diagnosis of asthma for a period of at least 1 year as per GINA guideline.

排除标准

  • 1.Patients who had an asthma attack/exacerbation requiring systemic steroid/hospitalization.
  • 2.Patients whoever had required intubation for severe asthma.
  • 3.Patient’s clinical condition worsened by ICS administration.
  • 4.Patients with a history of chronic lung disease other than asthma i.e. COPD, Sarcoidosis ,ILD.

结局指标

主要结局

Spirometry

时间窗: 0, 3rd, 7th, 14th & 28th day

次要结局

  • Renal function test, Hemogram,Liver function test(0 & 28th day)

研究者

申办方类型
Government medical college

研究点 (1)

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