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Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation

NCT ID: NCT01560689

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Bronchiolitis Obliterans Allogeneic Stem Cell Transplantation

Keywords

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bone marrow transplantation obstructive lung disease bronchodilators inhaled steroids late-onset pulmonary complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BUDESONIDE/FORMOTEROL

Group Type ACTIVE_COMPARATOR

Budesonide/formoterol

Intervention Type DRUG

800 µg/j twice a day, every day

control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Twice a day, every day

Interventions

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Budesonide/formoterol

800 µg/j twice a day, every day

Intervention Type DRUG

Placebo

Twice a day, every day

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Anne Bergeron

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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bergeron-lafaurie Anne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pneumology Department, Hopital Saint Louis

Locations

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Hopital Saint Louis APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id