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

Primary Purpose

Obstructive Airway Disease

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Formoterol/Budesonide

lactose

About this trial

This is an interventional treatment trial for Obstructive Airway Disease focused on measuring Obstructive airway disease, bronchiolitis obliterans, allogeneic hematopoietic stem cell transplantation, bone marrow transplantation, inhaled treatment, Budesonide Formoterol

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hôpital Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

Patients with OAD will receive lactose as a placebo, administered by inhalation using the Turbuhaler (TH) system

Outcomes

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.

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

Full Information

NCT ID

NCT00624754

First Posted

February 15, 2008

Last Updated

May 3, 2013

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00624754

Brief Title

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

Acronym

Alloforb

Official Title

recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Airway Disease

Keywords

Obstructive airway disease, bronchiolitis obliterans, allogeneic hematopoietic stem cell transplantation, bone marrow transplantation, inhaled treatment, Budesonide Formoterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Patients with OAD will receive lactose as a placebo, administered by inhalation using the Turbuhaler (TH) system

Intervention Type

Drug

Intervention Name(s)

Formoterol/Budesonide

Intervention Description

Budesonide/Formoterol 400/12: 800 µg b.i.d for 1 month

Intervention Type

Drug

Intervention Name(s)

lactose

Intervention Description

Lactose 2 puffs b.i.d for 1 month

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

1, 6 and 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne BERGERON

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Saint Louis

City

Paris

ZIP/Postal Code

75010

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

17351647

Citation

Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socie 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. doi: 10.1038/sj.bmt.1705637. Epub 2007 Mar 12.

Results Reference

background

PubMed Identifier

25835160

Citation

Bergeron A, Chevret S, Chagnon K, Godet C, Bergot E, Peffault de Latour R, Dominique S, de Revel T, Juvin K, Maillard N, Reman O, Contentin N, Robin M, Buzyn A, Socie G, Tazi A. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1242-9. doi: 10.1164/rccm.201410-1818OC.

Results Reference

derived

Learn more about this trial

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

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