The characterisation of bronchiectasis over 2 years with a trial of a low dose antibiotic in the second year with the aim of identifying characteristics that mean people show the most improvement whilst on the drug.

Phenotyping bronchiectasis based on aetiology, exacerbation characteristics and response to erythromycin. - Phenotyping bronchiectasis over 2 years including a macrolide trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002792-34-GB

Enrollment

Registered

2014-03-13

Start date

2014-02-26

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis MedDRA version: 16.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Erythromycin Product Name: Erythromycin Pharmaceutical Form: Tablet INN or Proposed INN: Erythromycin CAS Number: 114-07-8 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Group 1 - 40 participants over 2 years including the intervention - Patients who have clinical symptoms suggestive of bronchiectasis confirmed by CT scan. - Aged 18-100. - Ability to give valid consent. - Willingness to attend the hospital every 3 months for 2 years. Group 2 - 50 participants for baseline visit only - Patients who have clinical symptoms suggestive of bronchiectasis confirmed by CT scan. - Aged 18-100. - Ability to give valid consent. - Willingness to attend the hospital for a one off visit. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Group 1 - 40 participants over 2 years including the intervention - Active TB. - Patients under 18 and over 100. - Patients who are too unwell to attend visits. - Patients with known cystic fibrosis. - Patients with traction bronchiectasis secondary to fibrosis. - Patients who are unable to consent. - Patients already on long term antibiotics. - Patients with macrolide allergy / severe intolerance / prolonged QT interval. - Patients taking medication with a known interaction with erythromycin where the use is contraindicated, with the exception of simvastatin. Group 2 - 50 participants for baseline visit only - Active TB. - Patients under 18 and over 100. - Patients who are too unwell to attend visits. - Patients with known cystic fibrosis. - Patients with traction bronchiectasis secondary to fibrosis. - Patients who are unable to consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Research tells us that erythromycin can reduce exacerbation frequency in bronchiectasis by greater than 50% with minimal side-effects. We know that this category of antibiotics (macrolides) can reduce sputum volume and improve quality of life by reducing lung inflammation rather than killing bacteria in a variety of different lung conditions. We also know from our own clinic data that in some patients a 3 month course of erythromycin can improve lung function by a considerable amount. The patients that improve the most have certain changes in the very small airways on their CT scans and have a lot of inflammatory cells in their sputum, called neutrophils. What we don't know is whether a 3 month course of the antibiotic would have as good an effect as the studies of longer courses of antibiotics and whether the effect is sustained over the course of a year. We also would like to find out whether there are any tests which can predict whether an individual is likely to have a good or poor;Secondary Objective: The secondary objectives are as follows: - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months. - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics. ;Primary end point(s): Primary Aim - We anticipate an improvement in the FEV1 of at least 200ml following a 3 month course of erythromycin at 250mg once a day. Primary Hypothesis - We hypothesize that neutrophilic airway inflammation the most common phenotype in our study population and that this group will have the best response to low dose erythromycin. ;Timepoint(s) of evaluation of this end point: The study will run for 2 years for each person.	—

Measure

Time frame

Main Objective: Research tells us that erythromycin can reduce exacerbation frequency in bronchiectasis by greater than 50% with minimal side-effects. We know that this category of antibiotics (macrolides) can reduce sputum volume and improve quality of life by reducing lung inflammation rather than killing bacteria in a variety of different lung conditions. We also know from our own clinic data that in some patients a 3 month course of erythromycin can improve lung function by a considerable amount. The patients that improve the most have certain changes in the very small airways on their CT scans and have a lot of inflammatory cells in their sputum, called neutrophils. What we don't know is whether a 3 month course of the antibiotic would have as good an effect as the studies of longer courses of antibiotics and whether the effect is sustained over the course of a year. We also would like to find out whether there are any tests which can predict whether an individual is likely to have a good or poor;Secondary Objective: The secondary objectives are as follows: - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months. - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics. ;Primary end point(s): Primary Aim - We anticipate an improvement in the FEV1 of at least 200ml following a 3 month course of erythromycin at 250mg once a day. Primary Hypothesis - We hypothesize that neutrophilic airway inflammation the most common phenotype in our study population and that this group will have the best response to low dose erythromycin. ;Timepoint(s) of evaluation of this end point: The study will run for 2 years for each person.

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Secondary

Measure	Time frame
Secondary end point(s): - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months. - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics. ;Timepoint(s) of evaluation of this end point: 2 years per person.	—

Measure

Time frame

Secondary end point(s): - To evaluate whether any response to 3 months of erythromycin is sustained over 12 months. - To create phenotypes based upon inflammatory markers in blood and sputum, underlying cause and severity of the bronchiectasis, lung function and non-invasive small airway measurements while stable and during exacerbations including response to antibiotics. ;Timepoint(s) of evaluation of this end point: 2 years per person.

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Countries

United Kingdom

Contacts

Public ContactProfessor Andrew Wardlaw

University Hospitals Leicester

aw24@le.ac.uk01162583370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026