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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00624754 |
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Date of registration:
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15/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT
Alloforb |
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Scientific title:
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recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00624754 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Anne BERGERON |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Airway Disease
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Intervention(s)
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Drug: lactose
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Drug: Formoterol/Budesonide
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Primary Outcome(s)
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The primary endpoint is based on pulmonary function tests (PFT): the absolute variation of FEV1 after 1 month of treatment will be assessed.
[Time Frame: 1 month]
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Secondary Outcome(s)
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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
[Time Frame: 1, 6 and 7 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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