Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation

Phase 2

Completed

• Conditions: Bronchiolitis Obliterans; Allogeneic Stem Cell Transplantation
• Interventions: Drug: Budesonide/formoterol; Drug: Placebo

• Registration Number: NCT01560689
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BUDESONIDE/FORMOTEROL	Budesonide/formoterol	-
control	Placebo	-

Primary Outcome Measures

Name	Time	Method
pulmonary function tests	1 month
Dyspnea based on NYHA classification	1 month

Secondary Outcome Measures

Name	Time	Method
pulmonary function test	7 month

Trial Locations

Locations (1)

Hopital Saint Louis APHP; 🇫🇷 Paris, France