Trial Outcomes & Findings for CARE FOR ALL：an Evaluation of an Asthma QIP (NCT NCT05440097)
NCT ID: NCT05440097
Last Updated: 2026-01-02
Results Overview
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.
COMPLETED
PHASE4
1500 participants
Baseline to week 48
2026-01-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Total
Total of all participants
|
|---|---|
|
Overall Study
STARTED
|
1500
|
|
Overall Study
Full Analysis Set
|
1362
|
|
Overall Study
COMPLETED
|
1271
|
|
Overall Study
NOT COMPLETED
|
229
|
Reasons for withdrawal
| Measure |
Total
Total of all participants
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
154
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
56
|
|
Overall Study
Include "enrolled by mistake" and "withdrawed by mistake".
|
15
|
Baseline Characteristics
CARE FOR ALL：an Evaluation of an Asthma QIP
Baseline characteristics by cohort
| Measure |
Total
n=1362 Participants
Total of all participants
|
|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 14.19 • n=228 Participants
|
|
Sex: Female, Male
Female
|
800 Participants
n=228 Participants
|
|
Sex: Female, Male
Male
|
562 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1362 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 48Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
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.
Outcome measures
| Measure |
Full Analysis Set
n=1362 Participants
All enrolled participants with at least one non-missing post-intervention GINA treatment assessment were enrolled into FAS.
|
|---|---|
|
Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment
Baseline
|
571 Participants
|
|
Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment
Week 48
|
723 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
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.
Outcome measures
| Measure |
Full Analysis Set
n=1362 Participants
All enrolled participants with at least one non-missing post-intervention GINA treatment assessment were enrolled into FAS.
|
|---|---|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, week 12, 24, 36 and 48Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
Outcome measures
| Measure |
Full Analysis Set
n=1362 Participants
All enrolled participants with at least one non-missing post-intervention GINA treatment assessment were enrolled into FAS.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, week 12, 24, 36 and 48Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
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.
Outcome measures
| Measure |
Full Analysis Set
n=1362 Participants
All enrolled participants with at least one non-missing post-intervention GINA treatment assessment were enrolled into FAS.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, week 12, 24 and 36Population: All successfully enrolled participating patients were followed up for up to 48 weeks and returned to recruiting hospital for study visits every 12 weeks.
Outcome measures
| Measure |
Full Analysis Set
n=1362 Participants
All enrolled participants with at least one non-missing post-intervention GINA treatment assessment were enrolled into FAS.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Total
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60