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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560689
First Posted: March 22, 2012
Last Update Posted: September 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Bergeron, Assistance Publique - Hôpitaux de Paris
  Purpose
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 Intervention Phase
Bronchiolitis Obliterans Allogeneic Stem Cell Transplantation Drug: Budesonide/formoterol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anne Bergeron, Assistance Publique - Hôpitaux de Paris:

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

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

Enrollment: 32
Study Start Date: June 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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


Locations
France
Hopital Saint Louis APHP
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: bergeron-lafaurie Anne, MD, PhD Pneumology Department, Hopital Saint Louis
  More Information

Responsible Party: Anne Bergeron, MD, PhD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01560689     History of Changes
Other Study ID Numbers: 2
First Submitted: March 20, 2012
First Posted: March 22, 2012
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
bronchodilators
inhaled steroids
late-onset pulmonary complication

Additional relevant MeSH terms:
Bronchiolitis Obliterans
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists