A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000485-36-GB

Enrollment

Registered

2006-09-18

Start date

2006-08-23

Completion date

Unknown

Last updated

2012-08-14

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

Conditions

Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS)

Interventions

Product Name: Azithromycin Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Lung transplant recipient 2. Male or Female 3. Age 16 years or over 4. Airflow limitation – FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Airflow limitation caused by other clinical problems (e.g clinical infection) 2. Known hypersensitivity to Azithromycin or any of the macrolide antibiotics 3. Participation in another drug related trial within 90days 4. Severe renal or hepatic impairment 5. Use of concomitant medication that would interact with azithromycin

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of azithromycin therapy in lung transplant recipients with BOS by determining the change in FEV1 after 3 months ;Secondary Objective: Secondary outcome measures: To measure the change in airflow limitation by measuring other indices of airflow obstruction ie FEV1/FVC, exhaled Nitric Oxide, total lung capacity measured by body plethysmography, phase 3 of the alveolar plateau measured by single breath oxygen washout, exercise capacity as measured by the 6 minute walk test. To measure the change in health status as measured by the Short Form 36 and Chronic Respiratory Questionnaire Inflammatory end points for the study will be change in BAL and airway biopsy neutrophil counts From Bronchoscopic bronchoalveolar lavage (BAL) fluid The change in BAL sCD14 The change in quorum signal levels The change in BAL LPS Clinical microbiological testing, to include quantitative PCR for cytomegalovirus Change in scar collagen deposition in the airway Change in reticular basement membrane thickening, in airway biopsies ;Primary end point(s): The primary end point will be the change in lung function measured by spirometry, FEV1, measured over 3 months.	—

Measure

Time frame

Main Objective: To determine the efficacy of azithromycin therapy in lung transplant recipients with BOS by determining the change in FEV1 after 3 months ;Secondary Objective: Secondary outcome measures: To measure the change in airflow limitation by measuring other indices of airflow obstruction ie FEV1/FVC, exhaled Nitric Oxide, total lung capacity measured by body plethysmography, phase 3 of the alveolar plateau measured by single breath oxygen washout, exercise capacity as measured by the 6 minute walk test. To measure the change in health status as measured by the Short Form 36 and Chronic Respiratory Questionnaire Inflammatory end points for the study will be change in BAL and airway biopsy neutrophil counts From Bronchoscopic bronchoalveolar lavage (BAL) fluid The change in BAL sCD14 The change in quorum signal levels The change in BAL LPS Clinical microbiological testing, to include quantitative PCR for cytomegalovirus Change in scar collagen deposition in the airway Change in reticular basement membrane thickening, in airway biopsies ;Primary end point(s): The primary end point will be the change in lung function measured by spirometry, FEV1, measured over 3 months.

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Countries

United Kingdom

Outcome results

None listed

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