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

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ClinicalTrials.gov Identifier: NCT02902471
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Bone Marrow Transplantation Other: Forced oscillations measure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Evaluation of Distal Airways by Forced Oscillations: Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation
Study Start Date : June 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902471


Locations
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Jean-Louis Couderc, MD, PhD Hopital Foch

Publications:
Smith HJ, Reinhold P, Goldman MD. Forced Oscillation Technique and Impulse Oscillometry. Lung Function Testing: European Respiratory Society Monograph. Sheffield, England: European Respiratory Society; 2005:72-105

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02902471     History of Changes
Other Study ID Numbers: 2010/48
2010-A01229-30 ( Other Identifier: ANSM )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections