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临床试验/CTRI/2017/09/009804
CTRI/2017/09/009804已完成3 期

To Evaluate Efficacy And Safety Of Oral Inhalation Of Fixed Dose Combination Of Glycopyrronium and Formoterol Fumarate Powder for Inhalation (25 plus 6 mcg) As Compared To Marketed Glycopyrronium Powder for Inhalation 50 mcg In Patients With Chronic Obstructive Pulmonary Disease

Restech Pharmaceuticals0 个研究点目标入组 330 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
330
研究概览入排标准研究者记录与标识符相似试验

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

  • •Patients diagnosed with moderate to severe COPD as per the GOLD Guidelines classification at the time of screening:
  • •Post-bronchodilator FEV1/FVC ratio < 0.7;
  • •Post-bronchodilator FEV1 >= 30% to < 80% predicted
  • •-Patients who are current/ex-smokers or patients who have been exposed to other noxious stimuli which led to development of COPD
  • •- Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
  • •- Written informed consent from the patient
  • •-Patient literate enough to fill the diary card and willing to comply with the protocol requirements

排除标准

  • •-Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
  • •- Patients with known α1 antitrypsin deficiency
  • •- COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
  • •- Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
  • •- Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
  • •- Patients who require long-term oxygen therapy (>=12 hours/day) within 4 weeks prior to the screening or during the screening period
  • •- Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
  • •- Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
  • •- Patients with clinically significant uncontrolled diseases of either of the systems: cardiovascular, renal, neurological, psychiatric, endocrine, immunological, hematological disorders or malignancy
  • •-Clinically significant prolongation of QTc interval ( > 450 msec) at the time of screening.
  • •- Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >= 2.5 mg/dl)
  • •- Patients with continuing history of alcohol and/or drug abuse
  • •- Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
  • •- Participation in another clinical trial in the past 3 months
  • •- Any other reason for which the investigator feels that patient should not participate

研究者

发起方
Restech Pharmaceuticals

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