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

• Register: EUCTR
• Last refreshed on: 14 August 2012
• Main ID: EUCTR2006-000485-36-GB
• Date of registration: 18/09/2006
• Prospective Registration: No
• Primary sponsor: Newcastle upon Tyne Hospitals NHS Trust
• Public title: A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study
• Scientific title: A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study
• Date of first enrolment: 23/08/2006
• Target sample size: 64
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000485-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria:

1. Lung transplant recipient
2. Male or Female
3. Age 16 years or over
4. Airflow limitation – FEV1 < 80% maximum recorded post transplant
5. Ability to give Informed Consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): The primary end point will be the change in lung function measured by spirometry, FEV1, measured over 3 months.

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

Secondary ID(s)

G0500705