International Severe Asthma Registry_Hong Kong (ISAR)

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).

Study Overview

• Status: Recruiting
• Conditions: Asthma

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Wai San Fanny Ko, MD; Phone Number: +852 35053133; Email: fannyko@cuhk.edu.hk
• Study Contact Backup: Name: David Shu Cheong Hui, MD; Phone Number: +852 35053133; Email: dschui@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: David Shu Cheong Hui, MD; Phone Number: +852 35053133; Email: dschui@cuhk.edu.hk
    • Contact: Fanny Wai San Ko, MD; Phone Number: +852 35053133; Email: fannyko@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients who cannot provide written consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Asthma patients; Severe asthma patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2036

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: HK_ISAR_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are willing to share IPD provided the protocol/purpose is sound, as judged by our panel, and that patients' rights can be protected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No