To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

NCT04639791 | Recruiting

• 1 other identifier: Severe Asthma Management_v2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prospectively assess the asthma control and management of asthma patients who are on step 4, 5 asthma of GINA in Hong Kong (on at least medium-dose ICS-LABA as controller therapy for asthma) and also observe their exacerbations over 2 years. In addition, this study will also assess patients who are on biologics for their suitability and outcome. The investigators hope this study will be able to provided data regarding the management and outcome of patients who have difficult-to-treat and severe asthma. The investigators plan to build a biologic registry for asthma that would be able to help local doctors to gain experience to the use of these new and expensive medications. This is a multi-centre study involving public hospitals in Hong Kong. This study is important as this will generate local data for healthcare planning for severe asthma in Hong Kong.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Level of asthma control

  By GINA 2020 criteria of well-controlled, partly controlled or uncontrolled asthma

  24 months

• Asthma Exacerbation

  Exacerbation that requires treatment with oral steroid (for patients on maintenance oral steroid, then increase in dose of the oral steroid).

  24 months

• Hospitalization for asthma

  Number of hospitalization for asthma

  24 months

Study Arms (1)

Severe asthma patients

on step 4\& 5 of GINA treatment

Other: No intervention

Interventions

No intervention OTHER

Observation only, no intervention

Severe asthma patients

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

Asthma patients who are on Steps 4 and 5 of GINA asthma therapy

You may qualify if:

• Asthma patients with age ≥18. Asthma is defined as those with a consistent history and prior documented evidence of variable airflow obstruction.
• Subjects on steps 4 and 5 of GINA asthma therapy

You may not qualify if:

• Patients with respiratory diseases with other known respiratory diseases including chronic obstructive pulmonary disease, bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer
• Individuals older than 40 years with a smoking history of more than 10 pack-years
• Pregnant women

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, 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

Central Study Contacts

Fanny WS Ko, MD

CONTACT

85235053133; fannyko@cuhk.edu.hk

David SC Hui, MD

CONTACT

85235053133; dschui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: March 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

HK (1)