A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong

Bronchiectasis is associated with repeated exacerbations which occurs at rates of 1.5-6.5 per patients per year, and are associated with an increased risk of admission and readmission to hospital, and high health care costs. In a local study carried out more than 10 years ago, idiopathic disease dominates and patients with bronchiectasis are mainly female with high hospitalization and mortality rates; 21.9 cases per 100,000 and 2.7 cases per 100,000 respectively. Moreover, exacerbation characterized by increases in symptoms requiring antibiotic treatment is associated with disease progression and significant mortality. Updated prevalence of this disease with the characteristics of etiology, clinical presentation and outcomes are needed to guide further management plan.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis Adult

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Hong Kong
  • Please Select
    • Hong Kong, Please Select, Hong Kong
      • Recruiting
      • Chinese University of Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study of patients. We propose to recruit consecutive patients who are under care of the Respiratory Clinic at the Prince of Wales Hospital with the diagnosis of bronchiectasis defined by high-resolution Computed Tomography scan. Patients who recover from a recent admission the Prince of Wales Hospital with exacerbation of bronchiectasis will also be recruited.

Description

Inclusion Criteria:

1. Patients aged 18 years or older
2. Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
3. Diagnosis of bronchiectasis defined by high-resolution computed tomography scan

Exclusion Criteria:

1. History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis
2. Those who are unable to give consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of bronchiectasis exacerbation	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality rate	5 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Anticipated): August 29, 2027
• Study Completion (Anticipated): August 29, 2027

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: ProBronchiectasis/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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