CTRI/2010/091/000495已完成4 期
A gamma scintigraphy study to determine the lung deposition of inhaled aerosolized radiolabeled budesonide/formoterol(200/6mcg)in patients with COPD and Asthma (Phase IV study)
Glenmark Pharmaceuticals Ltd.,Glenmark House,HDO-Corporate Building,Wing-A, B.D. Sawant Marg, Chakala,Off Western Express Highway,Andheri (E) Mumbai 400099.0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •(i) Outpatients, men ≥ 40 years
- •(ii) COPD diagnosed as a forced expiratory volume in 1 second (FEV1) of no more than 65% of predicted, a ratio of FEV1 to forced vital capacity (FVC) of no more than 0.70 and who are current or former smokers (at least 10 pack
- •(iii) Patients with stable mild to moderate persistent asthma; asthma diagnosed as improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist; baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value; Stability was ascertained if the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days
- •(iv) Ability to master pMDI inhalation technique in dummy experiments
- •(v) Written informed consent by patients
- •(vi) Patients willing to follow up.
排除标准
- •For COPD Patients
- •(i) A history and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
- •(ii) Patients who have experienced COPD exacerbation requiring at least one of the following treatments, hospitalization and/or a course of systemic steroid within 4 weeks prior to the study start.
- •(iii) Patients with significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
- •Patients with congenital heart diseases, lung cancer, thoracic restrictive disorders or any other coexisting diseases influencing 3-yr survival.
- •For asthma patients
- •(i) Hospitalization due to asthma during the previous 3 months
- •(ii) Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- •(iii) Oral or systemic corticosteroids in the previous 4weeks;
- •(2) Patients unable to inhale pMDI properly and with consistency
- •(3)Patients with known hypersensitivity to budesonide or formoterol, Technetium 99 m to compounds structurally related to the study drugs or to any other component included
- •(4)Heavy smokers or patients with underlying respiratory problems interfering with vital capacity or giving rise to PFT abnormality or inconsistency
- •(5)Patients with osteoporosis or any condition predisposing to low bone density
- •(6)Patients receive an investigational drug within 30 days prior to admission to the study
- •(7)Patients with out of normal range values in any of the following laboratory blood tests: complete blood count, blood glucose, ionogram, AST, ALT, total bilirrubin, total proteins, urea, creatinine, total cholesterol and triglycerides and urine potassium levels.
- •(8)Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study
研究者
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