Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.


Clinical Trial Description

Bronchiolitis obliterans (BO) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (SCT), commonly attributed to graft versus host disease (GVHD), and carries a poor prognosis. Although immunosuppressive treatments (IS) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. Because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in BO. Thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled Budesonide/Formoterol combination (400/12 µg twice a day) without modifying systemic IS received by the patients. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01560689
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 2
Start date June 2008
Completion date July 2012

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