CTRI/2025/12/099427尚未招募4 期
The Safety and Effectiveness of Fixed dose combination of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate, 200mcg/12.5mcg/6mcg) Metered Dose Inhaler (MDI) for maintenance treatment of Chronic Obstructive Pulmonary Disease patients: A Multicenter, Prospective, Open Label, Single arm, Phase IV Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 7
研究概览
简要总结
The Safety and Effectiveness of Fixed dose combination of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler (MDI) for maintenance treatment of Chronic Obstructive Pulmonary Disease patients: A Multicenter, Prospective, Open Label, Single arm, Phase IV Study. Total population is 200 patients and Treatment duration is of 12 weeks. Primary objective of the study is To assess the safety of FDC of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD) , while secondary objective of the study is to evaluate the effectiveness of FDC of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged 18 years or above.
- •Patients diagnosed with COPD according to the GOLD 2025 guidelines.
- •COPD Assessment Test (CAT) score more than or equal to 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 6 weeks at the time of screening.
- •Patients willing to provide written informed consent, literate enough to fill the diary card, and comply with the protocol requirements.
排除标准
- •1.Patients with known hypersensitivity to Budesonide, Glycopyronium and Formoterol, other beta 2 agonists, other anti-muscarinic agents or other corticosteroids.
- •2.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- •3.Patients with known alpha 1 antitrypsin deficiency 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 with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 8.Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 9.Patients with hepatic dysfunction (Serum Glutamic Oxaloacetic Transaminase (SGOT) & Serum Glutamic Pyruvic Transaminase (SGPT) more than or equal to 3 times Upper Normal Limit) or renal dysfunction (serum creatinine more than or equal to 2.5 mg/dl) at screening 10.Patients with continuing history of alcohol and/or drug abuse 11.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 12.Participation in another clinical trial in the past 3 months 13.Any other reason for which the investigator feels that the patient should not participate.
研究者
Dr Jayesh Sanmukhani
Clinexcel Research
研究点 (7)
Loading locations...
相似试验
尚未招募
不适用
A clinical trial to study the effect of addition of Budesonide nebulisation to standard first line therapy in management of acute asthma exacerbations.CTRI/2024/07/070571Government Medical College and Hospital Chandigarh100
尚未招募
不适用
A clinical trial to comparatively evaluate budesonide versus fluticasone nebulisation for prevention of post operative sore throatCTRI/2024/08/072501Dayanand Medical College and Hospital159
尚未招募
3 期
Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 yearsCTRI/2026/01/102452Lupin Limited Pharmaceutical company134
招募中
4 期
Study on the Effectiveness of an Inhaled Budesonide-Formoterol Combination for Treating Acute Cough After Infections: A Double-Blind Trial with Placebo ComparisonCTRI/2024/09/073863Dr Arpit Kumar Saha158
招募中
4 期
A phase IV study to evaluate efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate powder for Inhalation in participants with Chronic Obstructive Pulmonary Disease (COPD)CTRI/2025/12/098826Zydus Healthcare Ltd.234