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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04808518
Collaborator
(none)
74
28
45.7
2.6
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Dec 10, 2019
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Bx reg group

    non-Bx reg group

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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 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)

    3. 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

    4. Daily Oral Corticosteroid use [Until 24 months from baseline]

      Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use

    5. 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

    6. MiniAQLQ score [Until 24 months from baseline]

      To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months

    7. 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.

    8. 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

    9. 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

    10. 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)

    Other Outcome Measures

    1. To describe baseline patients' background and clinical presentations by each biologic [Until 24 months from baseline]

      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.

    2. Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg [Until 24 months from baseline]

      To describe the proportion of these patient population in non-Bx reg; Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg

    3. Time to decrease 0.5 (at least) of ACQ-5 score and duration of asthma [Until 24 months from baseline]

      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)

    4. Treatment reality of each biologic [Until 24 months from baseline]

      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

    5. To describe the change of asthma control status after switching one biologic to other biologics by ACQ-5 score status [Until 24 months from baseline]

      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)

    6. To explore the factors related to non-responder in Bx reg group [Until 24 months from baseline]

      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] )

    7. Reason why biologics are not started within 12 weeks in non-Bx reg group [within 12 weeks from study start]

      To describe the reason why biologics are not started within 12 weeks in non-Bx reg group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aki-gun Fucyu Japan
    2 Research Site Asahikawa Japan
    3 Research Site Bunkyo Japan
    4 Research Site Fukuoka Japan
    5 Research Site Hamamatsu Japan
    6 Research Site Hiroshima Japan
    7 Research Site Ikoma Japan
    8 Research Site Itabashi Japan
    9 Research Site Kobe Japan
    10 Research Site Kumagaya Japan
    11 Research Site Maebashi Japan
    12 Research Site Meguro Japan
    13 Research Site Nagoya Japan
    14 Research Site Nangoku Japan
    15 Research Site Niigata Japan
    16 Research Site Okayama Japan
    17 Research Site Osakasayama Japan
    18 Research Site Osaka Japan
    19 Research Site Otsu Japan
    20 Research Site Sagamihara Japan
    21 Research Site Shinagawa Japan
    22 Research Site Shinjuku Japan
    23 Research Site Shizuoka Japan
    24 Research Site Toyoake Japan
    25 Research Site Tsukubo-gun Hayashima Japan
    26 Research Site Yamagata Japan
    27 Research Site Yokohama Japan
    28 Research Site Yonago Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04808518
    Other Study ID Numbers:
    • D3250R00062
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022