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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 184
- Locations
- 6
- Primary Endpoint
- To evaluate the safety of GFB MDI/DPI in treatment of patients with COPD in India in terms of -
Study Overview
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory lung disease that is characterized by chronic airflow limitation and persistent respiratory symptoms (e.g. dyspnoea, sputum production and cough). Assessment of safety and effectiveness of GFB triple therapy in real world Indian clinical setting would be beneficial for further characterization of its safety and efficacy. Hence, this study has been planned to be conducted in Indian patients to observe its safety and effectiveness for GFB MDI and GFB DPI. The study is a prospective, open label, multicentre, single arm, interventional study to evaluate the safety and effectiveness of GFB MDI/DPI in the management of COPD among Indian patients. Treatment and study duration is of 24 weeks including 4 physical visits and 2 telephonic visits.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 40.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients more than or equal to 40 years’ age with a documented physician diagnosis of COPD.
- •Symptomatic patients receiving ongoing maintenance therapy (ICS/LABA or LAMA or LABA/LAMA).
- •Patients with exacerbation history in past 1 year.
- •Ability to use MDI/DPI independently and correctly in view of the investigator.
- •Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol.
Exclusion Criteria
- •Documented diagnosis of current asthma.
- •Ongoing treatment with Triple therapy i.e. ICS/LABA/LAMA.
- •Subjects with any life threatening condition or requiring hospitalization for management of current condition.
- •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.
- •Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug.
Outcomes
Primary Outcomes
To evaluate the safety of GFB MDI/DPI in treatment of patients with COPD in India in terms of -
Time Frame: 24 weeks
Number of patients with any drug related treatment emergent adverse events (TEAEs). [Time frame: up to Week 24]
Time Frame: 24 weeks
Number of patients with TEAEs [Time Frame: up to Week 24]
Time Frame: 24 weeks
Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 24]
Time Frame: 24 weeks
Secondary Outcomes
- To evaluate the effectiveness of GFB MDI/DPI in treatment of patients with COPD in India in terms of -(Mean change in Trough FEV1 from baseline at week 24.)