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Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction

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.
 
ClinicalTrials.gov Identifier: NCT02836938
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine

Brief Summary:
It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.

Condition or disease Intervention/treatment
Chronic Lung Allograft Dysfunction (CLAD) Other: Collection of exhaled breath volatile organic compounds

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
Severe
Severe chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 3
Other: Collection of exhaled breath volatile organic compounds
Mild
Mild chronic lung allograft dysfunction (CLAD), bronchiolitis obliterans syndrome (BOS), stage 1-2
Other: Collection of exhaled breath volatile organic compounds
Control
Bronchiolitis obliterans syndrome (BOS), stage 0
Other: Collection of exhaled breath volatile organic compounds



Primary Outcome Measures :
  1. Concentration of exhaled breath volatile organic compounds [ Time Frame: one sample will be collected between 6 month and 20 years after lung transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group of transplant patients with and without signs of BOS
Criteria

Inclusion Criteria:

  • Outpatient bilateral lung transplant recipients including combined transplants

Exclusion Criteria:

  • Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria

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): NCT02836938


Locations
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Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Prof. Dr. Jens Hohlfeld
Hannover Medical School
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Responsible Party: Prof. Dr. Jens Hohlfeld, Prof. Dr., Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT02836938    
Other Study ID Numbers: TXVOC
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017