A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis

Phase 1

• Conditions: ymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection.; MedDRA version: 12.1Level: LLTClassification code 10006414Term: Bronchial biopsy abnormal; MedDRA version: 12.1Level: LLTClassification code 10025041Term: Lung biopsy abnormal; MedDRA version: 12.1Level: LLTClassification code 10063078Term: Bronchoalveolar lavage abnormal; MedDRA version: 12.1Level: LLTClassification code 10049083Term: Respiratory tract infection NOS; MedDRA version: 12.1Level: LLTClassification code 10016547Term: FEV; MedDRA version: 12.1Level: LLTClassification code 10016549Term: FEV 1 abnormal; MedDRA version: 12.1Level: LLTClassification code 10016550Term: FEV 1 decreased; MedDRA version: 12.1Level: LLTClassification code 10016553Term: FEV 1 low; MedDRA version: 12.1Level: LLTClassification code 10057799Term: Computerised tomogram thorax abnormal

• Registration Number: EUCTR2010-018724-16-BE
• Lead Sponsor: KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-07
• Study Completion: 2012-12-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Able to take oral medication
- Histologic diagnosis of lymphocytic bronchiolitis or bronchitis without concurrent acute cellular allograft rejection
Are the trial subjects under 18? no
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

- Severe suture problems (e.g. airway stenosis) requiring lasering, dilatatation or stent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Treatment of lymphocytic bronchi(oli)tis: evolution of bronchial inflammation on histology, pulmonary function (FEV1), broncho-alveolar cellularity and radiologic features after 3 months of treatment with azithromycin.;Secondary Objective: - Evolution of pulmonary function (FEV1), broncho-alveolar cellularity and radiologic features after 6 and 12 months of treatment<br>- Outcome (bronchiolitis obliterans syndrome and mortality) after 1 and 2 years of treatment;Primary end point(s): - Histology on bronchial and/or transbronchial biopsies after 3 months<br>- Pulmonary function (FEV1) after 3 months<br>- Bronchoalveolar cellularity after 3 months<br>- Radiologic features after 3 months