A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)

Completed

• Conditions: Asthma

• Registration Number: NCT04808518
• Lead Sponsor: AstraZeneca

Brief Summary

Objectives in this study is to compare the change of lung function after 24 months from baseline between the two groups; one is the patient group who decided to start biologics treatment, and another is the patient group who decided to start non-biologics treatment. The target patients are the adult uncontrolled severe asthma patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-22
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Confirmed asthma diagnosis
2. Using high-dose ICSa and 2nd controllerb more than 3 months before registration
3. Uncontrolled asthma which constitutes one or more of 1) Poor symptom control: ACQ-5≧1.5 or ATC<20 2) Frequent exacerbations: at least 2 asthma exacerbations in the 12 months prior to the registration 3) Airflow obstruction: FEV1 before taking bronchodilator <80% predicted (FEV1/FVC less than the lower limit of normal) C
4. Investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators.
5. Patients deemed capable of visiting their study site next 24 months regularly
6. Patients from whom written consent to participate in this study has been obtained
7. Patients≧20 years old at obtaining consent

Exclusion Criteria

1. Participated in other interventional studies such as clinical trials, etc within the last 8 weeks.

2. Are using biologics at registration

3. Diagnosed as COPD

4. Plan the BT therapy near future

5. Receipt of any marketed or investigational biologics within 5 months before the registration

6. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

   • Affect the safety of the patient throughout the study
   • Influence the findings of the studies or their interpretations
   • Impede the patient's ability to complete the entire duration of study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1)	24 months from baseline	Change from baseline in post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) at 24 months

Secondary Outcome Measures

Name	Time	Method
Changes in Post-BD FEV1	Until 24 months from baseline	To describe the value of lung function decline in Bx reg and non-Bx reg by changes in Post-BD FEV1 from 6 months to 24 months, and from 12 months to 24 months
To compare the asthma control status between Bx reg and non-Bx reg	24 months from baseline	To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg -ACQ-5,Time to first asthma exacerbation and so on
Baseline patient background and clinical presentations between Bx reg and non-Bx reg	Until 24 months from baseline	To describe the baseline patient background and clinical presentations between Bx reg and non-Bx reg
Daily Oral Corticosteroid use	Until 24 months from baseline	Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use
MiniAQLQ score	Until 24 months from baseline	To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months
ACQ-5 score	24 months from baseline	To compare the differences of change from baseline in ACQ-5 score at 12 months and 24 months between both groups.; To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by ACQ-5 score.
Time to first asthma exacerbation	24 months from baseline	To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Time to first asthma exacerbation
Post-BD FEV1 by patient's background	Until 24 months from baseline	Change from baseline in post-bronchodilator FEV1 at 24 months by patient's background,; To compare the differences of change from baseline in post-BD FEV1 at 24 months between Bx reg and non-Bx reg, by the following patients' sub-groups; 1. Number of exacerbations during the study period (0, 1-2, 3-4, \>= 5); 2. asthma control level (mean ACQ-5 score between 6 months and 24 months; \<0.75, 0.75 - 1.5, \>1.5)
Annual rate of asthma exacerbations	24 months from baseline	To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Annual rate of asthma exacerbations
Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)	24 months from baseline	To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yonago, Japan