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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris AstraZeneca |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00624754 |
The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy.
Condition | Intervention | Phase |
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Obstructive Airway Disease |
Drug: Formoterol/Budesonide Drug: lactose |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients |
Estimated Enrollment: | 32 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients with OAD will receive Symbicort® at the dose of two puffs morning and evening, each delivering 400/12 µg of budesonide/formoterol. Symbicort® will be administered by inhalation using the Turbuhaler (TH) system
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Drug: Formoterol/Budesonide
Budesonide/Formoterol 400/12: 800 µg b.i.d for 1 month
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2: Placebo Comparator
Patients with OAD will receive lactose as a placebo, administered by inhalation using the Turbuhaler (TH) system
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Drug: lactose
Lactose 2 puffs b.i.d for 1 month
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Although it has not been evaluated prospectively, the usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy. However, this treatment has a limited efficacy and is associated with a significant number of serious adverse effects, particularly infectious.
Alternative treatments are therefore necessary.We have retrospectively reported clinical and functional improvement in patients with OAD following AHSCT treated with inhaled budesonide/formoterol combination.These encouraging results need to be confirmed by the present randomised, prospective double-blind trial. This study is therefore designed to evaluate the efficacy of budesonide/formoterol versus placebo in patients with moderate to severe OAD, not requiring initiation or intensification of systemic immunosuppressive therapy for extra thoracic GVHD.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne BERGERON, MD, PhD | +33(0) 1 42 49 96 18 | anne.bergeron-lafaurie@sls.aphp.fr |
France | |
Hôpital Saint Louis | Recruiting |
paris, France, 75010 | |
Contact: Anne BERGERON, MD, PhD +33(0) 1 42 49 96 18 anne.bergeron@sls.aphp.fr | |
Principal Investigator: Anne Bergeron, MD, PhD |
Principal Investigator: | Anne BERGERON | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Valérie MILLUL ) |
Study ID Numbers: | P070116 |
Study First Received: | February 15, 2008 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00624754 History of Changes |
Health Authority: | France: Ministry of Health |
Obstructive airway disease bronchiolitis obliterans allogeneic hematopoietic stem cell transplantation |
bone marrow transplantation inhaled treatment Budesonide Formoterol |
Anti-Inflammatory Agents Neurotransmitter Agents Lung Diseases, Interstitial Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Symbicort Hormone Antagonists Bronchiolitis Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents |
Hormones Glucocorticoids Adrenergic Agonists Bronchiolitis Obliterans Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Formoterol Bronchitis Peripheral Nervous System Agents Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Symbicort Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Adrenergic Agonists Bronchiolitis Obliterans Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Therapeutic Uses Formoterol Bronchitis Lung Diseases, Interstitial Adrenergic beta-Agonists Bronchiolitis Budesonide Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents |