AsthmaISARNCT07524543
International Severe Asthma Registry_Hong Kong
An observational study of Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To ensure the care of people with severe asthma continues to improve, it is essential we have detailed information on the health and treatment of as many people with the condition as possible. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Asthma
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2025to 31 Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe asthma either 1. on GINA Step 5 therapy 2. Asthma uncontrolled on GINA step 4 therapy (Uncontrolled can be poor symptom control in the past 12 months, persistent airflow limitation in the past 12 months, history of serious exacerbations or history of frequent exacerbations
Who may be able to join
- Patient with severe asthma with age 18 or over will be recruited.
Who cannot join
- Patients who cannot provide written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Fanny Wai San Ko, MD, +852 35053133, fannyko@cuhk.edu.hk
David Shu Cheong Hui, MD, +852 35053133, dschui@cuhk.edu.hk
About this study
Official title: International Severe Asthma Registry
To ensure the care of people with severe asthma continues to improve, it is essential we have detailed information on the health and treatment of as many people with the condition as possible. The purpose of the registry is to gather this information and track the progress of patients and how well they are responding to treatment. Medical research using data from the registry will provide a better understanding of asthma and help to develop and improve the care and treatment for patients with asthma.
Detailed protocol can be referred to the reference in this trial registration (International severe asthma registry [ISAR]: protocol for a global registry).
Read the detailed description
This registry is a multi-country, multicentre, observational initiative which will retrospectively and prospectively collect data regarding severe asthma patients. The key feature of the International Severe Asthma Registry will be a standardised annualised recording of:
A key set of severe asthma related data points Selected enhanced data points for optional additional data collection Standardised coding for data point variables and Standardised response options.
Asthma patients in Hong Kong will be contributing to this dataset/registry. All clinical information will be anonymised in the dataset to protect patient confidentiality.
- Conditions
- Asthma
- Keywords
- 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 group | Role | What they receive |
|---|---|---|
| Asthma patients | Severe asthma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbations
Number of asthma exacerbations per year
Measured: Every year up to 10 years
Secondary outcomes (1)
Change of medications
Change of asthma medications
Measured: every year up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny W.S. Ko, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524543
- Sponsor's protocol ID
- HK_ISAR_2025
- Acronym
- ISAR
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are willing to share IPD provided the protocol/purpose is sound, as judged by our panel, and that patients' rights can be protected.
Publications
FitzGerald JM, Tran TN, Alacqua M, Altraja A, Backer V, Bjermer L, Bjornsdottir U, Bourdin A, Brusselle G, Bulathsinhala L, Busby J, Canonica GW, Carter V, Chaudhry I, Cho YS, Christoff G, Cosio BG, Costello RW, Eleangovan N, Gibson PG, Heaney LG, Heffler E, Hew M, Hosseini N, Iwanaga T, Jackson DJ, Jones R, Koh MS, Le T, Lehtimaki L, Ludviksdottir D, Maitland-van der Zee AH, Menzies-Gow A, Murray RB, Papadopoulos NG, Perez-de-Llano L, Peters M, Pfeffer PE, Popov TA, Porsbjerg CM, Price CA, Rhee CK, Sadatsafavi M, Tohda Y, Wang E, Wechsler ME, Zangrilli J, Price DB. International severe asthma registry (ISAR): protocol for a global registry. BMC Med Res Methodol. 2020 Aug 14;20(1):212. doi: 10.1186/s12874-020-01065-0.
PubMed 32819285
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Severe Asthma Registry
- ClinicalTrials.gov ID
- NCT07524543
- Acronym / sponsor ID
- ISAR / HK_ISAR_2025
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 13 Apr 2026 (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.
To ensure the care of people with severe asthma continues to improve, it is essential we have detailed information on the health and treatment of as many people with the condition as possible. The purpose of the registry is to gather this information and track the progress of patients and how well they are responding to treatment. Medical research using data from the registry will provide a better understanding of asthma and help to develop and improve the care and treatment for patients with asthma.
Detailed protocol can be referred to the reference in this trial registration (International severe asthma registry [ISAR]: protocol for a global registry).
Detailed description
This registry is a multi-country, multicentre, observational initiative which will retrospectively and prospectively collect data regarding severe asthma patients. The key feature of the International Severe Asthma Registry will be a standardised annualised recording of:
A key set of severe asthma related data points Selected enhanced data points for optional additional data collection Standardised coding for data point variables and Standardised response options.
Asthma patients in Hong Kong will be contributing to this dataset/registry. All clinical information will be anonymised in the dataset to protect patient confidentiality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma patients | – | –Severe asthma patients |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe asthma either 1. on GINA Step 5 therapy 2. Asthma uncontrolled on GINA step 4 therapy (Uncontrolled can be poor symptom control in the past 12 months, persistent airflow limitation in the past 12 months, history of serious exacerbations or history of frequent exacerbations
Key inclusion criteria (1 listed)
- Patient with severe asthma with age 18 or over will be recruited.
Key exclusion criteria (1 listed)
- Patients who cannot provide written consent
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
Asthma exacerbations
Time frame: Every year up to 10 years
Number of asthma exacerbations per year
1 secondary outcome
Change of medications
Time frame: every year up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 32819285FitzGerald JM, Tran TN, Alacqua M, Altraja A, Backer V, Bjermer L, Bjornsdottir U, Bourdin A, Brusselle G, Bulathsinhala L, Busby J, Canonica GW, Carter V, Chaudhry I, Cho YS, Christoff G, Cosio BG, Costello RW, Eleangovan N, Gibson PG, Heaney LG, Heffler E, Hew M, Hosseini N, Iwanaga T, Jackson DJ, Jones R, Koh MS, Le T, Lehtimaki L, Ludviksdottir D, Maitland-van der Zee AH, Menzies-Gow A, Murray RB, Papadopoulos NG, Perez-de-Llano L, Peters M, Pfeffer PE, Popov TA, Porsbjerg CM, Price CA, Rhee CK, Sadatsafavi M, Tohda Y, Wang E, Wechsler ME, Zangrilli J, Price DB. International severe asthma registry (ISAR): protocol for a global registry. BMC Med Res Methodol. 2020 Aug 14;20(1):212. doi: 10.1186/s12874-020-01065-0.
- Individual participant dataSharing planned: Undecided. We are willing to share IPD provided the protocol/purpose is sound, as judged by our panel, and that patients' rights can be protected.
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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.
1 site 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 Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wai San Fanny Ko, MD (+852 35053133, fannyko@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbations (time frame: Every year up to 10 years). 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 NCT07524543, which also lists 1 linked publication.
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 13 Apr 2026.