Use of Biologics for Severe Asthma in Hong Kong

NCT06778746 | Recruiting

• 1 other identifier: CUHK_biologics_01
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The landscape of biologics therapy used in Hong Kong is currently unknown. The purpose of this study is to conduct a retrospective analysis of the use of biologics treatment for severe asthma in Hong Kong. The study aims to assess the landscape of biologics usage, evaluate the characteristics and conditions of patients before and after receiving biologic therapy, and provide insights into the effectiveness and safety of these treatments in the local population.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (6)

• To determine the prevalence and patterns of biologics utilization for severe asthma in Hong Kong.

  The usage of different biologics in percentages in the population of severe asthma is being studied.

  12 months

• To evaluate exacerbation rates before and after the initiation of biologic treatment.

  The number of exacerbations requiring systemic steroids before and 12 months after treatment with biologics.

  12 months

• To evaluate the asthma control before and after the initiation of biologic treatment.

  The asthma control was assessed using the asthma control test and GINA classification before and 12 months after treatment with biologics.

  12 months

• To evaluate the lung function before and after the initiation of biologic treatment.

  The changes in FEV1 percentage predicted before and 12 months after treatment with biologics.

  12 months

• To explore whether physicians are following international guidelines for the prescription of biologics

  Assess the percentage of patients with biologics were prescribed according to the Global Initiative for Asthma criteria.

  baseline

• To identify any adverse events associated with biologic therapy in the study population

  To assess any adverse events (including but not limited to headache, rash, allergic reaction, sore throat, tiredness) after using the biologics in 12 months

  12 months

Interventions

no interventions OTHER

No interventions, this is an observational study

Also known as: No interventions, this is an observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We surveyed all subjects with asthma subjects treated by biologics used in Hong Kong from CDARS or from patient lists drawn from local pharmacies of participating hospitals. Patients' electronic and paper medical records will be reviewed by the co-investigators at the respective hospital (respiratory physicians).

You may qualify if:

• Patients aged 18 years or older.
• Patients diagnosed with severe asthma per the Global Initiative for Asthma (GINA) guidelines.
• Patients who have received biologic therapy for treatment of asthma (including those who received just one dose to allow assessment of the reason for withdrawal)

You may not qualify if:

• \- Patients with respiratory diseases with other known significant respiratory diseases, including tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, NT, HK

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Fanny WS Ko, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny WS Ko, MD

CONTACT

852 35053133; fannyko@cuhk.edu.hk

David SC Hui, MD

CONTACT

852 35053133; dschui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory Medicine (clinical service)

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 16, 2025
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)