CTRI/2021/10/037155已完成3 期
A prospective, randomized, double blind, parallel, multicentre, phase III clinical trial to assess the efficacy and safety of Indacaterol and Budesonide Inhalation as compared to Formoterol Fumarate and Budesonide Inhalation in patients with Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
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 sex 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, ââ?°Â¥ 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 (CATTM) score ââ?°Â¥ 10
- •6. Patients with absolute eosinophil count > 100 cells/mcl at screening
- •7. Patients with history of at least one moderate exacerbation in last one year
- •8. Written informed consent from the patient
- •9. Patients literate enough to fill the diary card and willing to comply with the protocol requirements
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 diagnosed with COVID-19 in last 3 months
- •3. Patients with known Ã?±1 antitrypsin deficiency
- •4. Patients not on stable doses of LABA/LAMA since last 4 weeks
- •5. Patients who have used ICS in last 4 weeks
- •6. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •7. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- •8. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
- •9. Patients who required long-term oxygen therapy (ââ?°Â¥12 hours/day) within 4 weeks prior to the screening or during the screening period
- •10. Patients with known hypersensitivity to formoterol, Indacaterol, salbutamol or other beta-2 agonists
- •11. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •12. Patients with hepatic dysfunction (serum transaminases ââ?°Â¥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ââ?°Â¥ 2.5 mg/dl) at screening
- •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. Any other reason for which the investigator feels that the patient should not participate
研究者
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