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Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00624754•Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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.

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

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hôpital Saint Louis

Paris, France

Key Dates

Start Date

March 1, 2008

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

May 6, 2013

Enrollment

ACTUAL participants

Conditions

Obstructive Airway Disease

Interventions

Formoterol/Budesonide

DRUG

lactose

DRUG

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Cardiorespiratory and Vascular DysfunctionObstructive Airway Disease

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TERMINATEDNA

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Broncho-degenerative DiseaseChronic Obstructive Airway Disease+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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