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Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation (alloforb)

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ClinicalTrials.gov Identifier: NCT01560689
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Anne Bergeron, 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Allogeneic Stem Cell Transplantation Drug: Budesonide/formoterol Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation
Study Start Date : June 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Active Comparator: BUDESONIDE/FORMOTEROL Drug: Budesonide/formoterol
800 µg/j twice a day, every day
Other Name: Symbicort

Placebo Comparator: control Drug: Placebo
Twice a day, every day

Primary Outcome Measures :
  1. pulmonary function tests [ Time Frame: 1 month ]
  2. Dyspnea based on NYHA classification [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. pulmonary function test [ Time Frame: 7 month ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560689

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Hopital Saint Louis APHP
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: bergeron-lafaurie Anne, MD, PhD Pneumology Department, Hopital Saint Louis
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Responsible Party: Anne Bergeron, MD, PhD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01560689    
Other Study ID Numbers: 2
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Keywords provided by Anne Bergeron, Assistance Publique - Hôpitaux de Paris:
bone marrow transplantation
obstructive lung disease
inhaled steroids
late-onset pulmonary complication
Additional relevant MeSH terms:
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Bronchiolitis Obliterans
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action