Clinical Trials Logo
  1. Home
  2. Bronchiolitis Obliterans
  3. NCT01307462

Targeted Therapy of Bronchiolitis Obliterans Syndrome — FAM for BOS  

Bronchiolitis Obliterans Clinical Trial

Official title:
Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant

Clinical Trial Summary

This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine if the combination treatment of FAM administered in post hematopoietic cell transplantation (HCT) recipients after the diagnosis of new onset bronchiolitis obliterans syndrome (BOS) can decrease the rate of treatment failure relative to an estimated historical rate of 40% using current therapies.

SECONDARY OBJECTIVES:

I. To confirm the safety profile of FAM.

II. To describe the effect on other standard pulmonary function test parameters: forced expiratory flow at 25%-75% of forced vital capacity (FVC) (FEF25-75), residual volume (RV), diffusion capacity of carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1)/FVC ratio and FEV1/slow vital capacity (SVC) ratio with FAM treatment.

III. To determine the change in molecular markers of inflammation and fibrosis in the blood with FAM treatment.

IV. To assess the impact of FAM on other chronic graft-versus-host disease (GVHD) manifestations.

V. To assess the impact of FAM on functional status, and health-related quality of life (HRQOL).

VI. To describe changes in steroid dosing.

OUTLINE:

Patients receive fluticasone propionate inhaled orally (PO) twice daily (BID), azithromycin PO 3 days a week, and montelukast sodium PO once daily (QD). Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01307462
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Completed
Phase Phase 2
Start date June 2011
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03603899 - Hp129 Xenon Imaging and BOS in Lung Transplantation Phase 1/Phase 2
Recruiting NCT04098445 - TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
Completed NCT02441413 - Transplant Optimization Using Functional Imaging (TROFI) N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
Terminated NCT01163786 - A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD Phase 2
Recruiting NCT02627833 - Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO N/A
Completed NCT01212406 - Vitamin D in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT05922761 - BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) Phase 2
Recruiting NCT05881538 - High Intensity Intervallic Training in Children With Bronchiolitis Obliterans N/A
Terminated NCT04655508 - Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation Phase 3
Withdrawn NCT02109237 - Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3 N/A
Completed NCT01327248 - Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans N/A
Recruiting NCT05932316 - Evaluating Bronchodilator Response in Patients With Bronchiectasis N/A
Active, not recruiting NCT03656926 - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) Phase 3