Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

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 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 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 ≥ 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.