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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Anne Bergeron, Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01560689

First received: March 20, 2012

Last updated: September 6, 2012

Last verified: September 2012

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

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

Primary Outcome Measures:

pulmonary function tests [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Dyspnea based on NYHA classification [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pulmonary function test [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Anne Bergeron, MD, PhD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01560689 History of Changes
Other Study ID Numbers:	2
Study First Received:	March 20, 2012
Last Updated:	September 6, 2012
Health Authority:	France: Ministry of Health

Keywords provided by 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
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

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