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Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome (OSCILLOPOUMON)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01807975
First Posted: March 8, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).

Condition Intervention
Bronchiolitis Obliterans Syndrome Other: Forced oscillation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode). [ Time Frame: 2 years ]

Enrollment: 110
Study Start Date: September 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: post allogreffe patients
Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients
Other: Forced oscillation

  Eligibility

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

Inclusion Criteria:

  • Patients of more than 18 year-old.
  • Patients with cardiopulmonary transplant or bilateral lung transplant.
  • Clinically stable patients

Exclusion Criteria:

  • Patients already diagnosed with bronchiolitis obliterans.
  • Respiratory infection.
  • Acute graft rejection.
  • Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
  • Iatrogenic pneumopathy.
  • Inability to perform Respiratory function test.
  Contacts and Locations
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): NCT01807975


Locations
France
Hôpital FOCH
Suresnes, Ile de France, France, 92150
Sponsors and Collaborators
Hopital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01807975     History of Changes
Other Study ID Numbers: 2010/56
First Submitted: March 7, 2013
First Posted: March 8, 2013
Last Update Posted: July 28, 2016
Last Verified: May 2016

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