Clinical trial NCT05219630: Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
Official title: Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, PRO, BGF pMDI, CAT, RWD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Around 15 sites across Japan will participate in the study. At each site, the investigators (physicians) will enroll adult patients without asthma history with COPD who initiates BGF pMDI as per the physicians' decision and during an outpatient visit at the in the clinics/hospitals.

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 period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response.

Study design:

This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12.

Data Source(s):

The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice

Statistical Analysis:

All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.

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 will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. To help contextualize the study result, KRONOS data will be referred where applicable.

Study Design:

This is a 12-week, prospective, multi-center, observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by physician in their routine clinical care will be consecutively invited for this study.

The day of the initiation of BGF pMDI treatment is called baseline, and the timing of fulfilling the eligibility criteria at baseline day is called the study entry.

Investigators (physicians) make screening their candidate patients who will be on the new prescription of BGF pMDI prior to the study entry and make explanation on informed consent at their usual visit timing. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice, and collect the data at baseline, at week 4 \[Week 3 (Day 21) to Week 7 (Day 49)\] and week 12 \[Week 10 (Day 70) to Week 14 (Day 98)\].

Data Source(s):

The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice

Statistical Analysis:

All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.

Eligibility criteria: Inclusion 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 320/18/9.6µg 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

Exclusion 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)

Primary outcomes:
measure: Mean changes from baseline in the CAT scores (total score) over week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean changes from baseline in the SGRQ scores (total score) over week 12
timeFrame: 12 weeks
measure: Mean changes from baseline in the SGRQ scores (total score) at week 4 and 12
timeFrame: 12 weeks
measure: To assess the achievement of MCID of SGRQ at 4 and 12 weeks from the initiation of BGF pMDI in COPD patients
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Toon
country: Japan
facility: Research Site
state: Ehime
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Tsuchiura
country: Japan
facility: Research Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Matsusaka
country: Japan
facility: Research Site
state: Mie
city: Kashihara
country: Japan
facility: Research Site
state: Nara
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
Study officials:
References: