At a glance
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The Effectiveness of Asthma Control Test Guided Treatment Compared With Usual Care in China Adult Asthma Patients
In Brief
A Phase 4 clinical trial evaluating ACT guided Routine Treatment and Routine Treatment for Asthma. Completed, enrolled 530 participants across 6 sites.
Detailed Summary
This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided treatment compared with usual care in asthma subjects in China. It is designed to assist Chinese subjects and physicians improving adherence to the guidelines through the inclusion of the ACT in the patient's asthma management plan. This is a prospective, multicentre, cluster-randomized, open-label 24-week study. In this cluster-randomization design, each study center, considered as a cluster, will be randomized to either ACT guided treatment group or control group (usual care group). For the subjects who are recruited in the ACT centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for more than equal to (\>=) 3 months then the treatment will stepped-down; if ACT score \>=20, less than (\<) 25 or ACT=25 for \<3 months then there will be no change and if ACT score less than (\<=) 19 then the treatment will stepped-up. For subjects who are recruited in the control centers, they will be treated based on doctor's subjective judgment. Assignment to a treatment will not occur, as no treatment intervention is provided for this study. A total of 528 asthma subjects are planned in the study. The randomization will be stratified according to the Tier of the hospitals (Tier 3 verses Tier 2).
Study Details
Timeline
Interventions
The ACT is a validated, short, easy to use, and self-administered instrument used to assess asthma control. Subjects in this group received routine treatment as per ACT score.
Subjects in the controlled treatment group will receive usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.