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.

Phase 1

• Conditions: Bronchiectasis; MedDRA version: 16.1Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-002792-34-GB
• Lead Sponsor: niversity Hospitals Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified