Change in symptom and quality of life in COPD by Budesonide/Glycopyrronium/Formoterol pressurized metered dose inhaler (BGF pMDI):a prospective, multi-centers, observational study

JRCT ID: jRCT1031210548

Registered date:13/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: chronic obstructive pulmonary disease
• Date of first enrollment: 13/01/2022
• Target sample size: 107
• Study type: Observational

Outcome(s)

• Primary Outcome: Mean changes from baseline in the CAT scores (total score) over week 12

Secondary Outcome

<Secondary Objectives>
1. Mean changes from baseline in the SGRQ scores(total score) over week 12
2. Mean changes from baseline in the SGRQ scores(total score) at week 4 and 12
3. Mean changes from baseline in the CAT scores(total score) at week 4 and 12
4. Achievement rate of MCID(change of >=4 from baseline) in SGRQ score at week 4 and 12
5. Achievement rate of MCID(change of >=2 from baseline) in CAT scores at week 4 and 12
<Exploratory Objectives>
1. Mean changes from baseline in the SGRQ scores in 3 domains(i.e, symptoms, activities and impacts) at week 4 and 12
2. Mean changes from baseline in the CAT scores in each item at week 4 and 12
3. Patient characteristics in baseline in 2 groups of patients who achieved and not achieved MCID of SGRQ at week 4 and 12(outcomes of secondary objective 1)
4. Mean changes from baseline in BDI/TDI(total score) at week 12
5. Mean changes from baseline in CASA-Q at week 12

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male or female patients aged >=40 years old at study entry
2. 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)
3. Patients who is on the new prescription of BGF pMDI 320/18/9.6ug twice daily as per the physician's decision, at baseline
4. Patients with CAT>=10 at study entry
5. Patients who are capable to fill PROs physically and/or mentally as judged by investigators
6. Patients who provide written informed consent prior to the study entry

Exclude criteria

1. Patients diagnosed as asthma by investigator's judgement at and/or before study entry
2. 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
3. Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
4. Patients with history of exacerbation during 4 weeks before the study entry
5. 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)

Related Information

• Primary Sponsor: Tanaka Michio