NCT04538859

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Aug 2020Aug 2027

Study Start

First participant enrolled

August 30, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2027

Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

7 years

First QC Date

August 31, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of bronchiectasis exacerbation

    5 years

Secondary Outcomes (1)

  • Mortality rate

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong

Hong Kong, Please Select, Hong Kong

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 4, 2020

Study Start

August 30, 2020

Primary Completion (Estimated)

August 29, 2027

Study Completion (Estimated)

August 29, 2027

Last Updated

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations