Asthma
Conditions
Brief summary
This is an evaluation on an asthma Quality Improvement Program (QIP, including GINA guideline education/training and implementation) to understand the change of physician behaviours, which leads to the change of patient outcomes. Primary endpoint is Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48 . A total of around 30 eligible Tier 3 and Tier 2 hospitals will be selected across China. Approximately 1500 eligible asthmatic patients fulfilling the following inclusion and exclusion criteria will be enrolled consecutively from participating hospitals,. The QIP (including GINA guideline education/training and implementation) will be delivered at the hospital level, targeting all pulmonologists and specialist nurses at participating hospitals, including initial comprehensive education, reinforcement learning, and performance assessment and feedback of pulmonologists' guideline implementation, along with multiple online and offline approaches serving as reminders and supportive tools to ensure consistent education and to facilitate the asthma management in routine clinical practice in accordance with GINA recommendation. After the initiation of the intervention program participating patients will return to the study hospital every 12 weeks for on-site follow-up visits (V1 to V5), in accordance with guideline recommendations. Meanwhile, investigators are mandatory requested to join in reinforce education at regular time. Guideline implementation performance will be assessed against with multi-approach indicators for each participant's offline or online visit. The objective of the CARE FOR ALL study is to bridge the gap that exists between the recommendations from GINA 2021 and current clinical practice by demonstrating the benefits of an asthma quality improvement program (QIP), i.e. a standardized pulmonologist-targeted GINA guideline education and practice implementation.
Interventions
OTHERQIP intervention
The QIP includes pulmonologist-targeted guideline education and guideline implementation. Guideline education includes the initial comprehensive training and reinforcement learning. The initial comprehensive education will be delivered at each participating hospital by a dedicated national asthma expert team, immediately after last patient enrolled at each site. The PI of respiratory departments from participating hospitals are responsible for arranging the delivery of hospital-level reinforcement learnings and ensuring the quality and success of hospital-level guideline implementation. The pulmonologists' guideline adherence and performance at participating hospitals will be regularly assessed during the study period.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant must be 14 years of age or older at the time of signing the informed consent. 2. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g. from bronchodilator reversibility testing or other test) 3. Participating patients and/or their legally authorised representative must provide signed and dated written informed consent form prior to any study specific procedures.
Exclusion criteria
1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma 2. Any significant disease or disorder (e.g. cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study 3. Disease or condition other than asthma that requires treatment with systemic or oral steroids 4. Participation in another clinical study with an Investigational Product administered in the last 3 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment | Baseline to week 48 | Change from baseline in the proportion of patients with an ICS-based maintenance and/or reliever treatment at week 48 was performed using mixed effect logistic regression model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48 | Baseline to Week 48 | The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. Mean scores of ≤0.75 indicate well controlled asthma, 0.75-1.5 indicate partly controlled asthma, and ≥1.5 indicates not well controlled asthma. |
| Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Baseline, week 12, 24, 36 and 48 | — |
| Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 | Baseline, week 12, 24, 36 and 48 | The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. |
| Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36 | Baseline, week 12, 24 and 36 | — |
Countries
China
Participant flow
Recruitment details
This single-arm study assessed a hospital-level Quality Improvement Program (QIP) in 31 Chinese hospitals (29 Jul 2022 - 03 Sep 2024). The QIP was a standardized GINA 2021 guideline education intervention delivered to 282 engaged pulmonologists. Participant Population (Outcome Assessors): Consecutive asthma patients from these hospitals were screened; 1,536 were screened and 1,500 were enrolled to be managed by the trained pulmonologists.
Pre-assignment details
For Pulmonologists: All participating pulmonologists from the 31 hospitals received the QIP intervention. There was no control group of pulmonologists .Baseline data were not collected for Pulmonologists. For Patients: All enrolled patients were managed by pulmonologists who had received the QIP. Patients were not randomized to different treatment strategies; the study aimed to observe the change in their outcomes before and after their physicians received the QIP.
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Include enrolled by mistake and withdrawed by mistake. | 15 |
| Overall Study | Lost to Follow-up | 56 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 154 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 14.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1362 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 800 Participants |
| Sex: Female, Male Male | 562 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment
Change from baseline in the proportion of patients with an ICS-based maintenance and/or reliever treatment at week 48 was performed using mixed effect logistic regression model.
Time frame: Baseline to week 48
Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment | Baseline | 571 Participants |
| Full Analysis Set | Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment | Week 48 | 723 Participants |
p-value: <0.000195% CI: [9.079, 13.431]Mixed Models Analysis
Secondary
Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48
The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. Mean scores of ≤0.75 indicate well controlled asthma, 0.75-1.5 indicate partly controlled asthma, and ≥1.5 indicates not well controlled asthma.
Time frame: Baseline to Week 48
Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48 | Baseline | 354 Participants |
| Full Analysis Set | Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48 | Week 48 | 641 Participants |
95% CI: [26.82, 34.25]Normal approximation
Secondary
Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48
Time frame: Baseline, week 12, 24, 36 and 48
Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Baseline | 2 Participants |
| Full Analysis Set | Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Week 12 | 15 Participants |
| Full Analysis Set | Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Week 24 | 12 Participants |
| Full Analysis Set | Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Week 36 | 64 Participants |
| Full Analysis Set | Secondary Endpoint 2- Change From Baseline in the Proportion of Patients on the Treatment of ICS-formoterol as Reliever at Week 12, 24, 36 and 48 | Week 48 | 84 Participants |
95% CI: [0.77, 3.58]Normal approximation
95% CI: [0.57, 3.56]Normal approximation
95% CI: [9.25, 15.13]Normal approximation
95% CI: [10.32, 15.79]Normal approximation
Secondary
Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48
The Asthma Control Questionnaire-5 (ACQ-5) is a shortened version of the full 7-item ACQ (Juniper et al 1999) that assesses asthma symptoms (night-time awakening, symptoms on awakening, activity limitation, shortness of breath, and wheezing). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses.
Time frame: Baseline, week 12, 24, 36 and 48
Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 | Week 12 | -0.59 Scores on a scale | Standard Deviation 1.132 |
| Full Analysis Set | Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 | Week 24 | -0.65 Scores on a scale | Standard Deviation 1.168 |
| Full Analysis Set | Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 | Week 36 | -0.61 Scores on a scale | Standard Deviation 1.142 |
| Full Analysis Set | Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 | Week 48 | -0.71 Scores on a scale | Standard Deviation 1.132 |
Secondary
Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36
Time frame: Baseline, week 12, 24 and 36
Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36 | Baseline | 571 Participants |
| Full Analysis Set | Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36 | Week 12 | 677 Participants |
| Full Analysis Set | Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36 | Week 24 | 577 Participants |
| Full Analysis Set | Secondary Endpoint 4- Change From Baseline in the Proportion of Participants With an ICS-based Maintenance and/or Reliever Treatment at Week 12, 24 and 36 | Week 36 | 590 Participants |
95% CI: [9.21, 16.85]Normal approximation
95% CI: [0.61, 8.23]Normal approximation
95% CI: [2.68, 10.36]Normal approximation