Asthma Control Test Guided Treatment in Chinese Subjects
Status:
Completed
Trial end date:
2019-08-09
Target enrollment:
Participant gender:
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).