Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT (Alloforb)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00624754
First received: February 15, 2008
Last updated: May 3, 2013
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Airway Disease |
Drug: Formoterol/Budesonide Drug: lactose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 32 |
| Study Start Date: | March 2008 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Drug: Formoterol/Budesonide
Budesonide/Formoterol 400/12: 800 µg b.i.d for 1 month
Other Name: Formoterol/Budesonide
|
|
Placebo Comparator: 2
Patients with OAD will receive lactose as a placebo, administered by inhalation using the Turbuhaler (TH) system
|
Drug: lactose
Lactose 2 puffs b.i.d for 1 month
Other Name: lactose
|
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 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.
Inclusion criteria modified according to amendment of 02/11/2009
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624754
Locations
| France | |
| Hôpital Saint Louis | |
| Paris, France, 75010 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
AstraZeneca
Investigators
| Principal Investigator: | Anne BERGERON | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00624754 History of Changes |
| Other Study ID Numbers: | P070116 |
| Study First Received: | February 15, 2008 |
| Last Updated: | May 3, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Obstructive airway disease bronchiolitis obliterans allogeneic hematopoietic stem cell transplantation |
bone marrow transplantation inhaled treatment Budesonide Formoterol |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis Obliterans Lung Diseases, Obstructive Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases Respiratory Tract Infections Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013