---
title: Azithromycin in Bronchiolitis Obliterans Syndrome
nct_id: NCT01009619
overall_status: COMPLETED
phase: PHASE4
sponsor: KU Leuven
study_type: INTERVENTIONAL
primary_condition: Bronchiolitis Obliterans Syndrome
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01009619.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01009619"
ct_last_update_post_date: 2011-10-03
last_seen_at: "2026-05-12T06:30:28.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Azithromycin in Bronchiolitis Obliterans Syndrome

**Official Title:** Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.

**NCT ID:** [NCT01009619](https://clinicaltrials.gov/study/NCT01009619)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 83
- **Lead Sponsor:** KU Leuven
- **Collaborators:** University Hospital, Gasthuisberg, Fund for Scientific Research, Flanders, Belgium
- **Conditions:** Bronchiolitis Obliterans Syndrome, Graft Rejection, Lymphocytic Bronchiolitis, Respiratory Infection
- **Start Date:** 2005-09
- **Completion Date:** 2009-12
- **CT.gov Last Update:** 2011-10-03

## Brief Summary

Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.

## Detailed Description

* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:azithromycin).
* Randomisation at discharge after informed consent.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Stable LTx recipients at discharge after transplantation.
* Signed informed consent
* Adult (age at least 18 years old at moment of transplantation)
* Able to take oral medication

Exclusion Criteria:

* Prolonged and/or complicated ICU-course after transplantation.
* Early (\<30 days post-transplant) post-operative death
* Major suture problems (airway stenosis or stent)
* Retransplantation (lung)
* Previous transplantation (solid organ)
* Multi-organ transplantation (lung+ other solid organ)
```

## Arms

- **Azithromycin** (EXPERIMENTAL) — 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
- **Placebo** (PLACEBO_COMPARATOR) — PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.

## Interventions

- **Azithromycin** (DRUG) — Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period.
- **Placebo** (DRUG) — Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.

## Primary Outcomes

- **Prevalence of Bronchiolitis Obliterans Syndrome (BOS)** _(time frame: 2 years post-transplant)_ — BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.
- **Overall Survival** _(time frame: 2 years post-transplant)_ — Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.

## Secondary Outcomes

- **Acute Rejection Incidence Rate** _(time frame: 2 years post-transplant)_
- **Infection Incidence Rate** _(time frame: 2 years post-transplant)_
- **Pulmonary Function** _(time frame: during first two years post-transplant)_
- **Broncho-alveolar (BAL) Neutrophilia** _(time frame: during first two years post-transplant)_
- **Plasma C-reactive Protein (CRP) Levels** _(time frame: during the first two years post-transplant)_

## Locations (1)

- Katholieke Universiteit Leuven and University Hospital Gasthuisberg, Leuven, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.katholieke universiteit leuven and university hospital gasthuisberg|leuven||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01009619.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01009619*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*