Status:
COMPLETED
Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
Lead Sponsor:
AstraZeneca
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week ...
Detailed Description
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12 weeks in duration, the initial 4 weeks...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥40 years old at study entry
- Patients diagnosed with COPD (based on post-bronchodilator forced expiratory volume 11/flow volume curve percent predicted forced (FEV1/FVC)\<70% in the past and current or former smokers with a smoking history of ≥10 pack-years in the past)
- Patients who is on the new prescription of BGF pMDI 320/18/9.6µg twice daily as per the physician's decision, at baseline
- Patients with CAT≥10 at study entry
- Patients who are capable to fill PROs physically and/or mentally as judged by investigators
- Patients who provide written informed consent prior to the study entry
Exclusion
- Patients diagnosed as asthma by investigator's judgement at and/or before study entry
- Patients who participated in any interventional clinical studies and/or any relevant studies (quality of life (QoL) and respiratory researches) during the 12 weeks before the study entry and/or during this study
- Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
- Patients with history of exacerbation during 4 weeks before the study entry
- Patients with very severe comorbidities or status which would impact on QoL evaluation judged by investigators (e.g., heart failure, malignancy, receiving home oxygen therapy, pneumonia)
Key Trial Info
Start Date :
May 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05219630
Start Date
May 16 2022
End Date
May 30 2023
Last Update
April 23 2024
Active Locations (17)
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1
Research Site
Nagoya, Aichi-ken, Japan
2
Research Site
Seto, Aichi-ken, Japan
3
Research Site
Tōon, Ehime, Japan
4
Research Site
Kurume, Fukuoka, Japan