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Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation (OSCILLOMOELL)

Primary Purpose

Bronchiolitis Obliterans, Bone Marrow Transplantation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Forced oscillations measure
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis Obliterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years
  • Bone marrow or hematopoietic stem cells transplantation for more than 100 days
  • Clinical stability
  • Patients affiliated to a social security system
  • Patients having given his (her) written consent.

Exclusion Criteria:

  • Bronchiolitis Obliterans already diagnosed
  • Unresolved Respiratory infection
  • Unresolved mechanical complication (pneumothorax, effusions)
  • Medicinal pneumopathy
  • Inability to perform pulmonary function tests

Sites / Locations

  • CHRU de Lille
  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Patients with bronchiolitis obliterans syndrome after bone marrow transplantation

Outcomes

Primary Outcome Measures

Number of days
Temporal difference between the date of the functional change measured by the technique of the forced oscillations and by the standard techniques of plethysmography.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2016
Last Updated
July 13, 2018
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02902471
Brief Title
Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation
Acronym
OSCILLOMOELL
Official Title
Functional Evaluation of Distal Airways by Forced Oscillations: Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans syndrome in patients after bone marrow transplantation. The force oscillations technique will be compared with classical spirometry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans, Bone Marrow Transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients with bronchiolitis obliterans syndrome after bone marrow transplantation
Intervention Type
Other
Intervention Name(s)
Forced oscillations measure
Primary Outcome Measure Information:
Title
Number of days
Description
Temporal difference between the date of the functional change measured by the technique of the forced oscillations and by the standard techniques of plethysmography.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years Bone marrow or hematopoietic stem cells transplantation for more than 100 days Clinical stability Patients affiliated to a social security system Patients having given his (her) written consent. Exclusion Criteria: Bronchiolitis Obliterans already diagnosed Unresolved Respiratory infection Unresolved mechanical complication (pneumothorax, effusions) Medicinal pneumopathy Inability to perform pulmonary function tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Couderc, MD, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
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Citation
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Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation

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