An Open label SIngle arm, Multicentric, PRospective, Phase IV study to evaluate the Safety and EFfectiveness of GlycOpyrronium/ FoRmoterolfumarate / Budesonide triple therapy (TT) in the management of COPD patiEnts.(AIR-FORCE Study) - AIR-FORCE study

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Patients more than or equal to 40 years’ age with a documented physician diagnosis of COPD. 2. Symptomatic patients receiving ongoing maintenance therapy (ICS/LABA or LAMA or LABA/LAMA). 3. Patients with exacerbation history in past 1 year. 4. Ability to use MDI/DPI independently and correctly in view of the investigator. 5. Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol.

•1. Documented diagnosis of current asthma.
•2. Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
•3. Subjects with any life threatening condition or requiring hospitalization for management of current condition.
•4. Women of childbearing potential are not restricted in this study, however it is expected
•that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
•5. Subjects with history of hypersensitivity to the active substance or to any of its excipients
•of study drug.

发起方

Glenmark Pharmaceuticals Ltd