NCT03272932

Brief Summary

This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and mortality of subjects will be followed up for 3 years.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2017Dec 2026

First Submitted

Initial submission to the registry

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

8.3 years

First QC Date

September 1, 2017

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.

    To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics. (Assessment: % of subjects with ACO among patients with asthma and COPD respectively)

    3 years

Secondary Outcomes (6)

  • Percentage of patient with treatment that is different from the guidelines recommendation

    3 years

  • The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)

    3 years

  • The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)

    3 years

  • Percentages of subjects with morbidity (e.g. congestive heart failure)

    3 years

  • Percentages of subjects with mortality

    3 years

  • +1 more secondary outcomes

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with asthma or COPD

You may qualify if:

  • Subjects must fulfil all of the following criteria:
  • All patients with confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC\<0.7 based on the medical records) 1 or asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 6
  • Aged \>40 years old
  • Signed written informed consent to participate in the study

You may not qualify if:

  • Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication) 1 or acute exacerbation of asthma by GINA guideline. 6
  • Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
  • Patients currently diagnosed with pneumonia and acute bronchitis
  • Patients currently randomized in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be stored for future genetic studies. As there is currently no good biomarker or genetic tests that can identify the cause or suggest the diagnosis of Asthma COPD overlap, this study would like to explore into this.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Fanny Ko, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 6, 2017

Study Start

September 15, 2017

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations