NCT05440097: CARE FOR ALL

CARE FOR ALL：an Evaluation of an Asthma QIP

Completed Phase 4 Results posted Last updated 2 January 2026

What this trial tests

Phase 4 trial testing QIP intervention in Asthma in 1,500 participants. Completed in 3 September 2024.

Timeline

29 July 2022

Primary endpoint
3 September 2024

3 September 2024

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,500
Start date	29 July 2022
Primary completion	3 September 2024
Estimated completion	3 September 2024
Sites	32 locations across China

Drugs / interventions tested

• QIP intervention

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

14 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment Primary · 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.

Baseline

Group	Value	95% CI
Full Analysis Set	571

Week 48

Group	Value	95% CI
Full Analysis Set	723

Secondary Endpoint 1- Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48 Secondary · 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.

Baseline

Group	Value	95% CI
Full Analysis Set	354

Week 48

Group	Value	95% CI
Full Analysis Set	641

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 Secondary · Baseline, week 12, 24, 36 and 48

Baseline

Group	Value	95% CI
Full Analysis Set	2

Week 12

Group	Value	95% CI
Full Analysis Set	15

Week 24

Group	Value	95% CI
Full Analysis Set	12

Week 36

Group	Value	95% CI
Full Analysis Set	64

Week 48

Group	Value	95% CI
Full Analysis Set	84

Secondary Endpoint 3- Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48 Secondary · 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.

Week 12

Group	Value	95% CI
Full Analysis Set	-0.59	± 1.132

Week 24

Group	Value	95% CI
Full Analysis Set	-0.65	± 1.168

Week 36

Group	Value	95% CI
Full Analysis Set	-0.61	± 1.142

Week 48

Group	Value	95% CI
Full Analysis Set	-0.71	± 1.132

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 Secondary · Baseline, week 12, 24 and 36

Baseline

Group	Value	95% CI
Full Analysis Set	571

Week 12

Group	Value	95% CI
Full Analysis Set	677

Week 24

Group	Value	95% CI
Full Analysis Set	577

Week 36

Group	Value	95% CI
Full Analysis Set	590

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study.
   Huang K, Wang W, Wang Y, Li Y, et al · · 2025 · cited 3× · PMID 39778197 · DOI 10.2196/65197
2. Asthma Control and Risk Factors for Poor Asthma Outcomes in Chinese Asthma Patients: Baseline Analysis of a Multi-Centre, Single-Arm Study (CARE4ALL).
   Huang K, Liu M, Wang W, Shi H, et al · · 2025 · cited 1× · PMID 40059338 · DOI 10.1111/all.16522
3. Improving Asthma Management Through a Quality Improvement Program: the CARE4ALL Study.
   Huang K, Shi H, Zheng W, Huang S, et al · · 2025 · PMID 41689572 · DOI 10.1016/j.jaip.2025.11.017