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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 (EBISU Study)

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

106

The mean age of the patients at baseline was 73.8 years, 89.2% were male, the mean body-mass index (BMI) was 22.45 kg/m2 (98 patients), and the percentage of current smokers was 31.4%. Patients with emphysema as COPD phenotype accounted for 83.3%, with a mean expiratory volume % in one second (%FEV1) of 57.66% (67 patients). COPD severity was Global Initiative for Chronic Obstructive Lung Disease (GOLD) I in 10.4%, GOLD II in 56.7%, GOLD III in 22.4%, and GOLD IV in 10.4% (67 patients). The proportion of patients who had a history of exacerbation in the past 12 months was 6.9%, and the proportion of patients who were treated with LAMA+LABA before enrollment in the study was 69.6%. The mean of CAT scores at baseline was 15.6 and the mean of SGRQ scores at baseline was 33.307.

106 patients were enrolled, and 102 patients were included in the FAS after excluding 4 patients who never visited the institution after enrollment.

N/A

In total, 102 patients were analysed; mean age at baseline was 73.8 years, mean % predicted FEV1 was 57.66%, CAT total score was 15.6 and SGRQ score was 33.3. The adjusted mean change from baseline in CAT was -2.9 (standard error [SE] 0.5) (p < 0.001), and SGRQ was -2.7 (SE 0.9) (p = 0.004) over 12 weeks. As early as Week 4, these scores were significantly improved from baseline.

Under clinical practice in Japan, statistically significant improvements were seen in symptoms and HRQoL at 12 weeks from the initiation of BGF pMDI in COPD patients with residual symptoms excluding pre-existing and current asthma.

May. 16, 2024

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1031210548

Tanaka Michio

AstraZeneca K.K.

Tower B, Grand Front Osaka, 3-1 Ofukacho, Kita-ku, Osaka-shi, Osaka

Michio.Tanaka@astrazeneca.com

Kato Yuki

AstraZeneca K.K.

Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka City, Osaka

+81-6-4802-3600

yuki.kato2@astrazeneca.com

Complete

Jan. 13, 2022

Observational

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

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)

Both

chronic obstructive pulmonary disease

D029424

Mean changes from baseline in the CAT scores (total score) over week 12

<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

+81-3-6416-1868

Dec. 16, 2021

none