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Completed

NCT Number: NCT04808518

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aki-gun Fucyu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed asthma diagnosis
  • Using high-dose ICSa and 2nd controllerb more than 3 months before registration
  • 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
  • Investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators.
  • Patients deemed capable of visiting their study site next 24 months regularly
  • Patients from whom written consent to participate in this study has been obtained
  • Patients≧20 years old at obtaining consent

Exclusion criteria

  • Participated in other interventional studies such as clinical trials, etc within the last 8 weeks.
  • Are using biologics at registration
  • Diagnosed as COPD
  • Plan the BT therapy near future
  • Receipt of any marketed or investigational biologics within 5 months before the registration
  • 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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1)

    Time frame: 24 months from baseline

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

Secondary outcomes

  1. Changes in Post-BD FEV1

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Until 24 months from baseline

    To describe the baseline patient background and clinical presentations between Bx reg and non-Bx reg

  6. MiniAQLQ score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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 outcomes

  1. To describe baseline patients' background and clinical presentations by each biologic

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: within 12 weeks from study start

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2021
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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