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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808518
• Other study ID #: D3250R00062
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Japan	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Daily Oral Corticosteroid use	Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use	Until 24 months from baseline
Secondary	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
Secondary	MiniAQLQ score	To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months	Until 24 months from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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