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

An Observational Primary Data Collection Study to Compare the Lung Function in the Adult Severe Asthma Patients Who Start Biologics Treatment and Who do Not Start, After Two-year Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Japan
  • Aki-gun Fucyu, Japan
    • Research Site
  • Asahikawa, Japan
    • Research Site
  • Bunkyo, Japan
    • Research Site
  • Fukuoka, Japan
    • Research Site
  • Hamamatsu, Japan
    • Research Site
  • Hiroshima, Japan
    • Research Site
  • Ikoma, Japan
    • Research Site
  • Itabashi, Japan
    • Research Site
  • Kobe, Japan
    • Research Site
  • Kumagaya, Japan
    • Research Site
  • Maebashi, Japan
    • Research Site
  • Meguro, Japan
    • Research Site
  • Nagoya, Japan
    • Research Site
  • Nangoku, Japan
    • Research Site
  • Niigata, Japan
    • Research Site
  • Okayama, Japan
    • Research Site
  • Osaka, Japan
    • Research Site
  • Osakasayama, Japan
    • Research Site
  • Otsu, Japan
    • Research Site
  • Sagamihara, Japan
    • Research Site
  • Shinagawa, Japan
    • Research Site
  • Shinjuku, Japan
    • Research Site
  • Shizuoka, Japan
    • Research Site
  • Toyoake, Japan
    • Research Site
  • Tsukubo-gun Hayashima, Japan
    • Research Site
  • Yamagata, Japan
    • Research Site
  • Yokohama, Japan
    • Research Site
  • Yonago, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Target patients in this study are the adult severe asthma patients whose asthma control status is uncontrolled based on the definition of ERS/ATS guideline. Also, the investigators judge the necessity of biologic treatment and explain the situation to these patient population.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bx reg group
non-Bx reg group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1)	Change from baseline in post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) at 24 months	24 months from baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe baseline patients' background and clinical presentations by each biologic	To describe baseline patients' background and clinical presentations by each biologic - Age, sex, , BMI, smoking history, history of pediatric asthma, duration of asthma, complications, comorbidities, blood eosinophils, FeNO, IgE, Atopic factor, etc.	Until 24 months from baseline
Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg	To describe the proportion of these patient population in non-Bx reg; Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg	Until 24 months from baseline
Time to decrease 0.5 (at least) of ACQ-5 score and duration of asthma	To evaluate the association between the time to decrease 0.5 of ACQ-5 and duration of asthma (< 10 years, 10<= and < 20 years, 20<= and < 30 years, >= 30 years)	Until 24 months from baseline
Treatment reality of each biologic	To describe the following information in Bx reg during the observational period; Reason why a biologic is switched to another biologic; Time to switch the biologic; Specific biologic at the first time, at the 2nd time, etc.; Chronological change of proportion of prescribed each biologic during the observational period	Until 24 months from baseline
To describe the change of asthma control status after switching one biologic to other biologics by ACQ-5 score status	To describe the change of asthma control status after switching one biologic to other biologics by the following ACQ-5 score status; ACQ-5 responder rate (respond; decrease of more than 0.5 score); Proportion of the following category by ACQ-5 score change pre/post switching (improve: -0.5 =<, no-change: -0.5< ACQ-5 <0.5, worse: >=0.5)	Until 24 months from baseline
To explore the factors related to non-responder in Bx reg group	To explore the factors related to non-responder at 24 months in Bx reg group (Definition of non-responder; ACQ-5 score decrease from the baseline is no more than 0.5[<0.5] )	Until 24 months from baseline
Reason why biologics are not started within 12 weeks in non-Bx reg group	To describe the reason why biologics are not started within 12 weeks in non-Bx reg group.	within 12 weeks from study start

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D3250R00062