CTRI/2023/03/050167已完成3 期
A prospective, randomized, double-blind, parallel, active-controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol and Glycopyrronium metered dose inhalation as compared to Glycopyrrolate and Formoterol fumarate metered dose inhalation in the patients with Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
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
- •1. Patients of either gender between 40-65 years of age (both inclusive)
- •2. Patients who are current/ex-smokers
- •3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit:
- •a. Post-bronchodilator FEV1/FVC ratio < 0.7;
- •b. Post-bronchodilator FEV1, = 30% to < 80% predicted
- •4. Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
- •5. COPD Assessment Test (CAT) score = 10 at screening
- •6. Patients willing to provide written informed consent and comply with the protocol requirements
- •7. Patients literate enough to fill the diary card
排除标准
- •1. Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- •2. Patients with known hypersensitivity to formoterol, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
- •3. Patients diagnosed with COVID-19 within 3 months prior to screening
- •4. Patients with known a1 antitrypsin deficiency
- •5. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •6. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- •7. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
- •8. Patients who required long-term oxygen therapy (=12 hours/day) within 4 weeks prior to the screening or during the screening period
- •9. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- •10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •11. Patients with hepatic dysfunction (serum transaminases = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl) at screening
- •12. Patients who have used prohibited medications
- •13. Patients with continuing history of alcohol and/or drug abuse
- •14. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •15. Participation in another clinical trial in the past 3 months
- •16. Any other reason for which the investigator feels that the patient should not participate
研究者
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