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Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation

NCT03072849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2024-11-19

No results posted yet for this study

Summary

This study aims to determine whether or not early spirometric detection and management of obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can attenuate declining lung function, prevent the development of bronchiolitis obliterans, and improve patient outcomes following hematopoietic stem cell transplant.

Conditions

  • Bronchiolitis Obliterans Syndrome

Interventions

PROCEDURE

Pulmonary function testing

Each enrolled patient will receive pulmonary function testing every three months. Pulmonary function testing includes spirometry, plethysmography, and diffusion capacity measurements.

DRUG

FAM Therapy

All patients who have evidence of early airflow obstruction on pulmonary function testing will be started on FAM therapy. Early airflow obstruction is defined by a FEV1 decline of ≥10% predicted in addition to a FVC \<0.8.

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-09-01
Completion
2020-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072849 on ClinicalTrials.gov