Bronchiectasis AdultNCT04538859
A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong
An observational study of Bronchiectasis Adult, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Aug 2020to 29 Aug 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis
- Those who are unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong
Hong Kong, Please Select
Susanna SS Ng, MBChB, (852) 35053493, ssng@cuhk.edu.hk
About this study
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.
- Conditions
- Bronchiectasis Adult
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bronchiectasis exacerbation
Measured: 5 years
Secondary outcomes (1)
Mortality rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start30 Aug 2020
- Primary completion29 Aug 2027 (estimated)
- Study completion29 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna SS Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538859
- Sponsor's protocol ID
- ProBronchiectasis/2019
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong
- ClinicalTrials.gov ID
- NCT04538859
- Acronym / sponsor ID
- ProBronchiectasis/2019
- Conditions
- Bronchiectasis Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis
- Those who are unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bronchiectasis exacerbation
Time frame: 5 years
1 secondary outcome
Mortality rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bronchiectasis exacerbation (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.