NCT04808518Completed
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 74 (actual)
- First submitted
- 5 Mar 2021
- Start date
- 10 Dec 2019
- Primary completion date
- 27 Nov 2023
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT04808518
What you commit to
- Study type: Observational
- Participants enrolled: 74
- From 10 Dec 2019 to the primary completion date, 27 Nov 2023
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Plan the BT therapy near future
- Receipt of any marketed or investigational biologics within 5 months before the registration
Other illness
- 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.
Other
- Participated in other interventional studies such as clinical trials, etc within the last 8 weeks.
- Are using biologics at registration
- Diagnosed as COPD
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.