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

July 13, 2018 updated by: Hopital Foch

Functional Evaluation of Distal Airways by Forced Oscillations: Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • CHRU de Lille
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients with bronchiolitis obliterans syndrome after bone marrow transplantation
Other: Forced oscillations measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days
Time Frame: 2 years
Temporal difference between the date of the functional change measured by the technique of the forced oscillations and by the standard techniques of plethysmography.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Jean-Louis Couderc, MD, PhD, Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/48
  • 2010-A01229-30 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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