Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAstraZeneca

About this trial

The primary objective of this study is to evaluate whether GDMT can bring significant benefits to disease management in uncontrolled asthma patients receiving medium- to high-dose ICS-LABA.

* The intervention period will be up to 48 weeks; * The frequency of follow-up is every 12 weeks.

Eligibility criteria

Qualifiers

Sign the informed consent form before any study-related procedures;

Age 18-75 years (inclusive) at Visit 0;

Have a written diagnosis of asthma for more than 6 months prior to Visit 0, and have evidence of reversible airflow limitation prior to Visit 0. Evidence of reversible airflow limitation includes: post-bronchodilator increase in Forced Expiratory Volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL, or average daily diurnal Peak Expiratory Flow (PEF) variability >10%, or an increase in FEV1 of ≥12% and an absolute increase of ≥200 mL compared to baseline after 4 weeks of treatment containing ICS, or a positive bronchial provocation test record. If no prior record exists, reversible airflow limitation must be confirmed and documented via a bronchodilator test during Visit 0;

Under the usage of MD/HD ICS-LABA;

Disqualifiers

Previous written diagnosis as "Severe Asthma"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing "severe asthma", or "bronchial asthma (severe)".

Imaging suggests the presence of bullae or cystic bronchiectasis;

Currently participating in other interventional studies;

Previous use of biologics for asthma treatment;

Trial design

Treatments tested in this trial

  • Intervention group

Treatment groups

540 Participants
are divided into 2 treatment groups

Sponsors and collaborators