CTRI/2023/03/050717已完成4 期
A prospective, single-arm, multicentre, phase IV clinical trial to assess the efficacy and safety of Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in patients with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
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:
- •o Post-bronchodilator FEV1/FVC ratio < 0.7;
- •o Post-bronchodilator FEV1, = 30% to < 80% predicted
- •4. COPD Assessment Test (CATTM) score = 10 even after receiving at least two inhaled maintenance therapies (LABA+ LAMA or LABA + ICS) for at least 4 weeks at the time of screening
- •5. Written informed consent from the patient
- •6. 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 with known a1 antitrypsin deficiency
- •3. Patients diagnosed with COVID-19 in last 3 months
- •4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •5. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- •6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
- •7. Patients who required long-term oxygen therapy (=12hours/day) within 4 weeks prior to the screening or during the screening period
- •8. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- •9. Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
- •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 with continuing history of alcohol and/or drug abuse
- •13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •14. Participation in another clinical trial in the past 3 months
- •15. Any other reason for which the investigator feels that the patient should not participate
研究者
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