Trial results for an evaluation of an Asthma Quality Improvement Program (QIP) were posted on ClinicalTrials.gov on 2026-01-02. The program demonstrated a statistically significant increase in the proportion of participants receiving ICS-based maintenance and/or reliever treatment by 12.79%.
Background
Asthma is a chronic respiratory condition that affects millions worldwide, requiring ongoing management to control symptoms and prevent exacerbations. Adherence to guideline-recommended treatments, such as inhaled corticosteroids (ICS) for maintenance and/or reliever therapy, is crucial for effective asthma control. Quality Improvement Programs (QIPs) are designed to enhance healthcare delivery by educating clinicians and implementing best practices, such as those outlined in GINA (Global Initiative for Asthma) guidelines. This study aimed to assess how such a program could influence physician behaviors and subsequently improve patient outcomes in asthma management.
Trial design
This completed Phase 4 study, titled "CARE FOR ALL：an Evaluation of an Asthma QIP," enrolled approximately 1500 eligible asthmatic patients across China. The trial focused on evaluating an asthma Quality Improvement Program, which included GINA guideline education, training, and implementation. The primary endpoint was the "Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48."
Key results
The trial reported several key findings from its analyses and measurements:
- Primary Endpoint: Change From Baseline in the Proportion of Patients With an ICS-based Maintenance and/or Reliever Treatment
- Analysis showed a "Difference in percentage" of 12.79 (95.0% CI: 9.079 to 13.431) with a p-value of 0.0001.
- The number of participants in the Full Analysis Set was 571 and 723.
- Secondary Endpoint 1: Change From Baseline in the Proportion of Participants With Well-controlled Asthma (ACQ-5 ≤ 0.75) at Week 48
- Analysis showed a "Difference in percentage" of 30.5 (95.0% CI: 26.82 to 34.25).
- The number of participants in the Full Analysis Set was 354 and 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
- Analyses showed "Difference in percentage" values of 2.2 (95.0% CI: 0.77 to 3.58), 2.1 (95.0% CI: 0.57 to 3.56), 12.2 (95.0% CI: 9.25 to 15.13), and 13.1 (95.0% CI: 10.32 to 15.79).
- The number of participants in the Full Analysis Set included 2, 15, 12, 64, and 84 participants at various time points.
- Secondary Endpoint 3: Change From Baseline in ACQ-5 Average Score at Week 12, 24, 36 and 48
- Mean changes from baseline in ACQ-5 average scores were -0.59 (Standard Deviation 1.132), -0.65 (Standard Deviation 1.168), and -0.61 (Standard Deviation 1.142) on a scale.
What this means
The results indicate that the Asthma Quality Improvement Program significantly improved the proportion of patients receiving ICS-based maintenance and/or reliever treatment, a key component of effective asthma management. The observed increases in well-controlled asthma and ICS-formoterol reliever use, alongside reductions in ACQ-5 scores, suggest that educational and implementation programs based on GINA guidelines can positively impact physician practice and patient outcomes. These findings support the value of structured quality improvement initiatives in enhancing adherence to clinical guidelines for asthma care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05440097, titled "CARE FOR ALL：an Evaluation of an Asthma QIP", were posted on 2026-01-02 on clinicaltrials.gov.