| February 15, 2008 |
| March 31, 2009 |
| March 2008 |
| September 2011 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00624754 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT |
| recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients |
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. |
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Obstructive Airway Disease |
- Drug: Formoterol/Budesonide
- Drug: lactose
|
- Experimental: Patients with OAD will receive Symbicort® at the dose of two puffs morning and evening, each delivering 400/12 µg of budesonide/formoterol. Symbicort® will be administered by inhalation using the Turbuhaler (TH) system
- Placebo Comparator: Patients with OAD will receive lactose as a placebo, administered by inhalation using the Turbuhaler (TH) system
|
| 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. |
| |
| Recruiting |
| 32 |
| October 2011 |
| September 2011 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 16 Years and older |
| No |
|
|
| France |
| |
| NCT00624754 |
| Valérie MILLUL, Department Clinical Research of Developpement |
| P070116 |
| Assistance Publique - Hôpitaux de Paris |
| AstraZeneca |
| Principal Investigator: |
Anne BERGERON |
Assistance Publique - Hôpitaux de Paris |
|
|
| Assistance Publique - Hôpitaux de Paris |
| January 2009 |
