Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01560689
• Date of registration: 20/03/2012
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation alloforb
• Scientific title: Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation
• Date of first enrolment: June 2008
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01560689
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: bergeron-lafaurie Anne, MD, PhD
• Affiliation: Pneumology Department, Hopital Saint Louis

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans

Allogeneic Stem Cell Transplantation

Intervention(s)

Drug: Budesonide/formoterol

Drug: Placebo

Primary Outcome(s)

Dyspnea based on NYHA classification [Time Frame: 1 month]

pulmonary function tests [Time Frame: 1 month]

Secondary Outcome(s)

pulmonary function test [Time Frame: 7 month]

Secondary ID(s)

2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors