CTRI/2025/12/098671招募中4 期
A post-marketing phase IV, multicentre, prospective study to observe the safety and tolerability of Breztri aerosphereR containing a fixed dose combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol fumarate dihydrate 5 mcg in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
研究概览
简要总结
This Phase IV, multicentre, open-label, single-arm post-marketing study (INDOS-B) is designed to evaluate the safety and tolerability of Breztri Aerosphere® (budesonide/glycopyrronium/formoterol) in Indian patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Approximately 166 participants will be enrolled across about 10 clinical sites in India and the participants will receive two actuations of Breztri Aerosphere® twice daily for 48 weeks, with a total study duration of 52 weeks including follow-up. Safety will be assessed through the monitoring of adverse events, serious adverse events, withdrawals due to adverse events, laboratory parameters, vital signs, ECGs, and spirometry. The study aims to generate long-term real-world evidence on the safety profile of Breztri Aerosphere® in the Indian COPD population.
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Patients with a physician-confirmed diagnosis of COPD a.
- •With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months (Please refer to 0 for the definition of COPD exacerbation.) b.
- •Post-bronchodilator FEV1 should be between greater than or equal to 30% to less than 80% predicted Sex and Contraceptive/Barrier Requirements Both adult male and female patients in the age group 18 years and above are allowed in the study.
- •a) Male participants: • must agree to use adequate contraception (male condom with spermicide; sterile sexual partner; or female sexual partner who uses an intrauterine device with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives) from study entry through at least 3 months after the last dose of study drug.
- •b) Female participants: i.
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal) ii.A urine pregnancy test must be negative at screening.
- •The childbearing potential has a negative urine pregnancy test at screening and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study (During screening).
- •a) Complete abstinence from intercourse (when it is preferred and the usual lifestyle of the patient) or b) Implants of levonorgestrel inserted for at least 1 month before the study drug administration but not beyond the third successive year following insertion or c) Injectable progestogen administered for at least 1 month before study drug administration; or d) Oral contraceptive (combined or progestogen-only) administered for at least one monthly cycle before study drug administration; or e) Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or f) An intrauterine device inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year or g) Estrogenic vaginal ring; or h) Percutaneous contraceptive patches.
- •Able to provide written informed consent.
排除标准
- •Exclusion Criteria: participants are excluded from the study if any of the following criteria apply:
- •Any pathology/underlying condition, which, in the Investigator’s opinion, may pose a risk to the patient’s participation in the study or may influence either the results of the study or the subject’s ability to participate in the study.
- •2.Chest X-ray within 14 days before screening must be acceptable to the investigator.
- •Subjects who have a chest X-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included.
- •A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.
- •Patients having moderate to severe exacerbations within 6 weeks before the Screening period.
- •Female patients who are pregnant or lactating or planning a family during the study period.
- •Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
- •Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.
研究者
Dr Naveed Nazir Shah
Government Chest Diseases Hospital
研究点 (1)
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