Moderate-to-Severe Asthma
Conditions
Brief summary
This is a Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD.
Detailed description
This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24. The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests) 2. Written informed consent 3. Moderate-to-severe asthma, which is defined as asthma patients with maintenance. treatment of GINA Step 3-5. 4. Age 12 years old and above
Exclusion criteria
1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma 2. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrolment. (Once enrolled in the PRESENT Study, patients should not enrol in any investigational trials.) 3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study 4. Disease or condition other than asthma that requires treatment with systemic or oral steroids 5. Patients with poor inhaler skills and adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Among those uncontrolled patients treated with low/medium-dose ICS/LABA at week 0, the proportion of patients escalate to high dose ICS/LABA and still uncontrolled over 24 weeks. | week 0, week 12 and week 24. | To describe the proportion of uncontrolled patients treated with low/medium-dose ICS/LABA escalated to high dose and fulfil the diagnosis of severe asthma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ACT(Asthma Control Test, The range of the total score can be from 5 to 25.) score at week 0, 12, 24 | week 0, week 12 and week 24 | To describe ACT of overall patients and of uncontrolled patients at baseline after 24-week follow up. |
| The proportion of controlled patients | week 0, week 12 and week 24 | To describe control status of overall patients and of uncontrolled patients at baseline after 24-week follow up. |
| The distribution of patients in different treatment pattern at week 0 and week 24. Treatment pattern includes: ICS, LABA, LAMA, SAMA, SABA, OCS, LTAR, Theophylline, biologics, macrolide antibiotics, ICS+LABA, LAMA+LABA, ICS+LABA+LAMA and other. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| The proportion of patients with low/medium/high-dose ICS at week 0,12 and 24 in overall patients and uncontrolled patients at baseline. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| The proportion of patients use maintenance dosage of OCS (prednisolone 40-50 mg/day or equivalent prednisone, continuously use ≥3 days) at week 0, 12 and 24 in overall patients and uncontrolled patients at baseline. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| Among those uncontrolled treated with low-dose ICS at week 0, the proportion of uncontrolled patients with medium -dose ICS and patients with high-dose ICS over week 24. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| Among those uncontrolled treated with medium-dose ICS at week 0, the proportion of patients with high-dose ICS over week 24. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| Among those uncontrolled treated with low/medium dose ICS at week 0, the proportion of patients with treatment pattern changes over week 24. | week 0, week 12 and week 24 | To describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients and to describe by different subgroups. |
| Annualized rate of exacerbations at week 0 visit for previous 12 months and at week 24 visit for follow up period | week 0, week 12 and week 24 | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. |
| ACT(Asthma Control Test)-related control status at week 0, 12 and 24. ACT scores of 20 to 25 denote well-controlled asthma, ACT scores ≤19 identifies patients with poorly controlled asthma. | week 0, week 12 and week 24 | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. |
| Lung function (pre-BD FEV1) at week 0, 12 and 24. | week 0, week 12 and week 24 | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. |
| Proportion of severe asthma among all patients according to GINA 2023, CN 2020 guideline and study defined severe asthma at week 0, 12 and 24 visit. | week 0, week 12 and week 24 | To describe proportions of severe asthma among moderate-to-severe asthma patients. |
| The bEOS level at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline. | week 0, week 12 and week 24 | To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA. |
| The proportion of stratification of bEOS (EOS<150/µL, ≥150 to <300/µL, ≥300/µL) at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline. | week 0, week 12 and week 24 | To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA. |
| The proportion of eosinophilic phenotype (eosinophilic asthma or not eosinophilic asthma) at week 0, 12 and 24 among uncontrolled patients treated with medium/high-dose ICS/LABA at baseline. | week 0, week 12 and week 24 | To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA. |
| The proportion of patients with bEOS ≥150/µL at week 24 among patients with EOS < 150/µL at baseline. | week 0, week 12 and week 24 | To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA. |
| The proportion of patients with bEOS ≥300/µL at week 24 among patients with EOS < 300/µL at baseline. | week 0, week 12 and week 24 | To describe eosinophils level and proportion of eosinophilic asthma among uncontrolled patients treated with medium/high-dose ICS/LABA. |
| Healthcare utilization at week 0, 12 and 24. | week 0, week 12 and week 24 | To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity. |
| Asthma-related medical cost: Total costs, including total hospital costs, total outpatient costs and total ER costs | week 0, week 12 and week 24 | To describe healthcare utilization2 of moderate-to-severe asthma patients and to describe by asthma severity. |
Countries
China
Outcome results
None listed