CTRI/2023/10/058791进行中（未招募）4 期
A prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease - NA
upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
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:
- •Post-bronchodilator FEV1/FVC ratio < 0.7
- •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 (=12 hours/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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