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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Diseases
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Budesonide
Formoterol
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014