Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease

Официальное название

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Обзор

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Подробное описание

Study details include:

The study duration will be 26 weeks The treatment duration will be 24 weeks

Вмешательства

• Препарат Breztri Aerosphere
  Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg

Первичные конечные точки

• To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

Patients with a physician-confirmed diagnosis of COPD

• With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months.
• Post-bronchodilator FEV1 should be between ≥30 % to <80% of the predicted normal.
• Both male and female patients are allowed in the study
• Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
• A urine pregnancy test must be negative at screening.
• female participant must follow effective contraceptive method as outlined in protocol
• Patients should be capable of giving signed informed consent

Критерии исключения

• Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
• Chest x-ray within 6 months 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индия · 5 центров

• Research Site — Dalgate, Drugjan
• Research Site — Hyderabad
• Research Site — Lucknow
• Research Site — Nagpur
• Research Site — New Delhi

Идентификаторы

NCT: NCT06531798 · D5980L00017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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