Status:
COMPLETED
Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
AstraZeneca
Conditions:
Obstructive Airway Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 intensific...
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 ...
Eligibility Criteria
Inclusion
- 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 6 months.
- AHSCT recipients who have developed moderate to severe bronchiolitis obliterans, defined by reduction of FEV1/VC below the 5th percentile of predicted normal or \< 80% of predicted, with FEV1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist. AHSCT recipients with FEV1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist and TLC ≥ 80% of predicted.
- 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
- 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 ≥ 80% 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00624754
Start Date
March 1 2008
End Date
July 1 2012
Last Update
May 6 2013
Active Locations (1)
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1
Hôpital Saint Louis
Paris, France, 75010