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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    300
  • sponsor
    AstraZeneca
Updated on 12 September 2021

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.

Details
Condition Asthma, Allergies & Asthma, Asthma (Pediatric), asthmatic, bronchial asthma
Clinical Study IdentifierNCT04808518
SponsorAstraZeneca
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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-51.5 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
Patients20 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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