AsthmaNCT04808518

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

An observational study of Asthma, run by AstraZeneca at 28 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Asthma
How many people: 74 participants
Where: 28 sitesJapan
Study dates: 10 Dec 2019to 27 Nov 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Target patients in this study are the adult severe asthma patients whose asthma control status is uncontrolled based on the definition of ERS/ATS guideline. Also, the investigators judge the necessity of biologic treatment and explain the situation to these patient population.

Who may be able to join

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

Who cannot join

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:

Show all 9Show fewer

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.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Japan28 sites

Research Site
Aki-gun Fucyu
Research Site
Asahikawa
Research Site
Bunkyō City
Research Site
Fukuoka
Research Site
Hamamatsu
Research Site
Hiroshima
Research Site
Ikoma
Research Site
Kobe
Research Site
Kumagaya
Research Site
Maebashi
Research Site
Meguro City
Research Site
Nagoya
Research Site
Nangōku
Research Site
Niigata
Research Site
Okayama
Research Site
Osaka
Research Site
Ōtsu
Research Site
Sagamihara
Research Site
Sayama
Research Site
Shinagawa City
Research Site
Shinjuku
Research Site
Shizuoka
Research Site
tabashi City
Research Site
Toyoake
Research Site
Tsukubo-gun Hayashima
Research Site
Yamagata
Research Site
Yokohama
Research Site
Yonago

Other trials in Japan

About this study

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

Conditions: Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04808518
Study group	Role	What they receive
Bx reg group		Not described
non-Bx reg group		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Changes in Post-BD FEV1
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
Measured: Until 24 months from baseline
Post-BD FEV1 by patient's background
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)
Measured: Until 24 months from baseline
To compare the asthma control status between Bx reg and non-Bx reg
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
Measured: 24 months from baseline
Daily Oral Corticosteroid use
Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use
Measured: Until 24 months from baseline
Baseline patient background and clinical presentations between Bx reg and non-Bx reg
To describe the baseline patient background and clinical presentations between Bx reg and non-Bx reg
Measured: Until 24 months from baseline
MiniAQLQ score
To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months
Measured: Until 24 months from baseline
ACQ-5 score
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.
Measured: 24 months from baseline
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 Time to first asthma exacerbation
Measured: 24 months from baseline
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 Annual rate of asthma exacerbations
Measured: 24 months from baseline
Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)
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)
Measured: 24 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201927 Nov 2023

First posted22 Mar 2021
Study start10 Dec 2019
Primary completion27 Nov 2023
Study completion27 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04808518
Sponsor's protocol ID: D3250R00062
Status last verified: Jul 2024
First submitted: 5 Mar 2021
Last updated: 23 Jul 2024
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04808518
Acronym / sponsor ID: D3250R00062
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Dec 2019 (actual)
Primary completion: 27 Nov 2023 (actual)
Study completion: 27 Nov 2023 (actual)
First posted: 22 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Bx reg group	–	–
non-Bx reg group	–	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Target patients in this study are the adult severe asthma patients whose asthma control status is uncontrolled based on the definition of ERS/ATS guideline. Also, the investigators judge the necessity of biologic treatment and explain the situation to these patient population.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

10 secondary outcomes

Changes in Post-BD FEV1
Time frame: Until 24 months from baseline
Post-BD FEV1 by patient's background
Time frame: Until 24 months from baseline
To compare the asthma control status between Bx reg and non-Bx reg
Time frame: 24 months from baseline
Daily Oral Corticosteroid use
Time frame: Until 24 months from baseline
Baseline patient background and clinical presentations between Bx reg and non-Bx reg
Time frame: Until 24 months from baseline
MiniAQLQ score
Time frame: Until 24 months from baseline
ACQ-5 score
Time frame: 24 months from baseline
Time to first asthma exacerbation
Time frame: 24 months from baseline
Annual rate of asthma exacerbations
Time frame: 24 months from baseline
Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)
Time frame: 24 months from baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
CSR SynopsisLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by AstraZeneca at 28 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) (time frame: 24 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.