NCT01560689

Brief Summary

The purpose of this study is to determine whether inhaled Budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

4.1 years

First QC Date

March 20, 2012

Last Update Submit

September 6, 2012

Conditions

Bronchiolitis ObliteransAllogeneic Stem Cell Transplantation

Keywords

bone marrow transplantationobstructive lung diseasebronchodilatorsinhaled steroidslate-onset pulmonary complication

Outcome Measures

Primary Outcomes (2)

  • pulmonary function tests

    1 month

  • Dyspnea based on NYHA classification

    1 month

Secondary Outcomes (1)

  • pulmonary function test

    7 month

Study Arms (2)

BUDESONIDE/FORMOTEROL

ACTIVE COMPARATOR
Drug: Budesonide/formoterol

control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Budesonide/formoterolDRUG

800 µg/j twice a day, every day

Also known as: Symbicort
BUDESONIDE/FORMOTEROL
PlaceboDRUG

Twice a day, every day

control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to BO, without extra-thoracic extensive graft versus host disease

You may not qualify if:

  • Extensive extra thoracic GVH necessitating increasing immunosuppressive treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Louis APHP

Paris, 75010, France

Location

MeSH Terms

Conditions

Bronchiolitis ObliteransLung Diseases, Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • bergeron-lafaurie Anne, MD, PhD

    Pneumology Department, Hopital Saint Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

June 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

FR(1)