Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation

Overview

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.

Full Title of Study: “Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2012

Detailed 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.

Interventions

  • Drug: Budesonide/formoterol
    • 800 µg/j twice a day, every day
  • Drug: Placebo
    • Twice a day, every day

Arms, Groups and Cohorts

  • Active Comparator: BUDESONIDE/FORMOTEROL
  • Placebo Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • pulmonary function tests
    • Time Frame: 1 month
  • Dyspnea based on NYHA classification
    • Time Frame: 1 month

Secondary Measures

  • pulmonary function test
    • Time Frame: 7 month

Participating in This Clinical Trial

Inclusion Criteria

  • adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease Exclusion Criteria:

  • Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anne Bergeron, MD, PhD – Assistance Publique – Hôpitaux de Paris
  • Overall Official(s)
    • bergeron-lafaurie Anne, MD, PhD, Principal Investigator, Pneumology Department, Hopital Saint Louis

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