EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

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.

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

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research Site

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

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

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

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
1）	Number of exacerbations during the study period (0, 1-2, 3-4, >= 5)
2）	asthma control level (mean ACQ-5 score between 6 months and 24 months; <0.75, 0.75 – 1.5, >1.5)

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

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

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

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

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.

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

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

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)

Arms	Assigned Interventions
Bx reg group	-
non-Bx reg group	-

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact