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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018724-16-BE

Enrollment

Registered

2010-04-07

Start date

2010-04-15

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Lymphocytic 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: 12.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal M

Interventions

Trade Name: Zitromax Product Name: Zitromax Product Code: Na Pharmaceutical Form: Capsule, hard INN or Proposed INN: OTHER SOURCES CAS Number: 117772700 Current Sponsor code: ZTM250 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - 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 - Pulmonary function (FEV1) after 3 months - Bronchoalveolar cellularity after 3 months - Radiologic features after 3 months	—

Measure

Time frame

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 - 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 - Pulmonary function (FEV1) after 3 months - Bronchoalveolar cellularity after 3 months - Radiologic features after 3 months

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Countries

Belgium

Outcome results

None listed

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