Clinical Assessment of glycOpyrrolate in COPD phenotypes and ACOS, a prospective, case control, observational study in outpatient settings of India (CAOS) - CAOS

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Newly diagnosed Patients aged >=40 years with COPD or ACOS diagnosis according to the current GINA/GOLD strategy who are symptomatic with >=1 exacerbation in the last year
•o In case ACOS, post-bronchodilator response improvement in FEV1 should be > 12% with 200 ml increase
•2. Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal at screening visit.
•3. >=10 pack years of smoking or biomass/household chullah/occupational dust exposure for >=10 years
•4. Patients who have no exacerbation within last 4 weeks
•5. Females patients with childbearing potential using effective birth control method
•6. Patients who signed written informed consent prior to participation
•7. Patients who accept to comply with the requirements of the protocol

•1. History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose
•2. Diagnosis of asthma
•3. Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period.
•4. Patients who had COPD exacerbation or lower respiratory tract infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period.
•5. Patients who have a history of myocardial infarction, heart failure, acute ischemic coronary disease or severe cardiac arrhythmia requiring treatment within last 6 weeks
•6. Patients with concomitant pulmonary disease, eg, pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder
•7. Patients who use oxygen therapy
•8. Patients with active liver disease or hepatic dysfunction (AST and/or ALT >3 x ULN) or Patients with nephrotic syndrome or renal insufficiency (sr. creatinine >1.5 mg/dl)
•9. Women who are pregnant or nursing
•10. Known symptomatic prostatic hypertrophy requiring drug therapy or operation
•11. Patients with narrow-angle glaucoma requiring drug therapy
•12. Patients receiving oral xanthines including theophylline, acebrophylline, deriphylline

发起方

Glenmark Pharmaceuticals Ltd