Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Airway Disease
Intervention: Formoterol/Budesonide (Drug); lactose (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Anne BERGERON, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Anne BERGERON, MD, PhD, Phone: +33(0) 1 42 49 96 18, Email: anne.bergeron-lafaurie@sls.aphp.fr
Summary
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.
Clinical Details
Official title: recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: The primary endpoint is based on pulmonary function tests (PFT): the absolute variation of FEV1 after 1 month of treatment will be assessed.
Secondary outcome: Improvement or stabilisation of FEV1;
Prevalence of improvement of FEV1 by at least 200 ml and 12% at 1 month compared to baseline;
Variation of FEF 25-75% and vital capacity;
Quality of life measurement;
Evaluation of the clinical score
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥16 years.
- Previous normal PFTs available.
- Absence of extrathoracic GVH disease justifying initiation or intensification of
systemic immunosuppressive therapy.
- Respiratory signs present for less than 1 year.
- AHSCT recipients who have developed moderate to severe bronchiolitis obliterans,
defined by reduction of FEV1/VC below the 5th percentile of predicted normal, with
FEV1 ≤ 70% of predicted normal and ≥ 40% of predicted normal , not reversible after
inhalation of short-acting beta-2 agonist.
- Respiratory symptoms related to obstructive lung disease present for at least 6
months.
- Negative respiratory microbiology work-up.
- Informed consent signed by the patient or both parents of a minor.
Exclusion Criteria:
- Extrathoracic graft versus host reaction justifying initiation or intensification of
systemic immunosuppressive therapy.
- Use of inhaled bronchodilator and/or corticosteroid therapy at the time of inclusion.
- Known intolerance to inhaled bronchodilators and/or corticosteroids and/or lactose.
- Personal or donor history of asthma.
- Active smoking
- FEV1 < 40% of predicted normal or > 70% of predicted normal or PO2 < 50 mmHg.
- Documented respiratory tract infection.
- Pregnancy.
- Absence of effective contraception during the trial.
- Not covered by French national health insurance.
Locations and Contacts
Anne BERGERON, MD, PhD, Phone: +33(0) 1 42 49 96 18, Email: anne.bergeron-lafaurie@sls.aphp.fr
Hôpital Saint Louis, paris 75010, France
Additional Information
Related publications: Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socié G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. Epub 2007 Mar 12.
Starting date: March 2008
Ending date: October 2011
Last updated: February 25, 2008
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