International Severe Asthma Registry_Hong Kong | NCT07524543

Studies
International Severe Asthma Registry_Hong Kong

NCT07524543

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Dec 31, 2035Estimated

Completion Date

Dec 31, 2036Estimated

First Submitted Date

Mar 28, 2026

First Submission Date that Met QC Criteria

Apr 5, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2026

Last Update Posted Date

Apr 13, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fanny W.S. Ko, Honorary Clinical Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
Asthma patients		Severe asthma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asthma exacerbations	Number of asthma exacerbations per year	Every year up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Change of medications	Change of asthma medications	every year up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with severe asthma with age 18 or over will be recruited.

Exclusion Criteria:

Patients who cannot provide written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with severe asthma either

on GINA Step 5 therapy
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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wai San Fanny Ko, MD	Contact	+852 35053133		fannyko@cuhk.edu.hk
David Shu Cheong Hui, MD	Contact	+852 35053133		dschui@cuhk.edu.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong	Recruiting	Hong Kong			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32819285	Background	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases