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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT02902471
First received: September 12, 2016
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
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 Intervention
Bronchiolitis Obliterans
Bone Marrow Transplantation
Other: Forced oscillations measure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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.


Enrollment: 110
Study Start Date: June 2011
Estimated Study Completion Date: March 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Patients with bronchiolitis obliterans syndrome after bone marrow transplantation
Other: Forced oscillations measure

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02902471

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

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 )
Study First Received: September 12, 2016
Last Updated: January 17, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on March 24, 2017