Bronchiectasis AdultNCT04658277
Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
A study testing Clarithromycin in people with Bronchiectasis Adult, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis. The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Clarithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50 years or older
- At least 2 or more exacerbation requiring antibiotic treatment in the past year 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 (CT) scan
Who cannot join
- History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis,
- Cigarette smoking within 6 months
- A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening
- Macrolide treatment for more than 3 months in the past 6 months
- Oral or intravenous courses of corticosteroids within 30 days of screening
- Any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks
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- Unstable arrhythmia
- History of coronary artery disease, or symptoms of heart disease
- Known allergy or intolerance to macrolides
- Patients with liver disease or with elevated transaminanse (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels equal to or greater than the upper limit of the normal)
- Concurrent medication: Colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.
Trial locations and contacts
1 site in 1 country.
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
clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis.
The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.
- Conditions
- Bronchiectasis Adult
- Being tested
- Clarithromycin, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Patients in the intervention arm will take Clarithromycin 250mg daily.
Usual careOther
Patients will receive usual medical care
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Patients will be given one tab of Clarithromycin 250mg daily. Receives: Drug: Clarithromycin |
| usual care | Placebo comparator | Patients will receive usual medical care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of infectious exacerbations
Measured: 26 weeks
Secondary outcomes (6)
Time to first exacerbation (Days)
Measured: 26 weeks
Rate of symptom-based exacerbations (number of events per month)
Measured: 26 weeks
change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity
Measured: 26 weeks
change of exercise capacity (flights of stairs)
Measured: 26 weeks
change of St George Respiratory Questionnaire Score
Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 26 weeks
change of concentration of serum c-reactive protein (mg/L)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT04658277
- Sponsor's protocol ID
- Macrolid/Bronchiectasis/2019
- Status last verified
- Oct 2021
- First submitted
- 31 Aug 2020
- Last updated
- 29 Oct 2021
- 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 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
- ClinicalTrials.gov ID
- NCT04658277
- Acronym / sponsor ID
- Macrolid/Bronchiectasis/2019
- Conditions
- Bronchiectasis Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Dec 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.
clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis.
The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: ClarithromycinPatients will be given one tab of Clarithromycin 250mg daily. |
| usual care | Placebo comparator | Other: Usual carePatients will receive usual medical care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 50 years or older
- At least 2 or more exacerbation requiring antibiotic treatment in the past year 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 (CT) scan
Key exclusion criteria (11 listed)
- History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis,
- Cigarette smoking within 6 months
- A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening
- Macrolide treatment for more than 3 months in the past 6 months
- Oral or intravenous courses of corticosteroids within 30 days of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClarithromycinPatients in the intervention arm will take Clarithromycin 250mg daily. | Drug | Treatment |
| Usual carePatients will receive usual medical care | Other | usual care |
Primary outcome
number of infectious exacerbations
Time frame: 26 weeks
6 secondary outcomes
Time to first exacerbation (Days)
Time frame: 26 weeks
Rate of symptom-based exacerbations (number of events per month)
Time frame: 26 weeks
change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity
Time frame: 26 weeks
change of exercise capacity (flights of stairs)
Time frame: 26 weeks
change of St George Respiratory Questionnaire Score
Time frame: 26 weeks
change of concentration of serum c-reactive protein (mg/L)
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarithromycin in people with 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 11 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 infectious exacerbations (time frame: 26 weeks). 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 29 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.