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Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02826265
Recruitment Status : Unknown
Verified March 2020 by Dr. Frederik Trinkmann, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Universitätsmedizin Mannheim

Study Description
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Brief Summary:
Current diagnostic tools used in pulmonary disease often do not meet the challenges set by the respective pathophysiology. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various pulmonary diseases.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Bronchial Asthma Interstitial Lung Disease Device: multiple breath washout test (MBW) Device: impulse oscillometry (IOS) Device: body plethysmography (BP) Device: quantitative computed tomography (qCT)

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
pulmonary disease
patients with known or suspected pulmonary disease
 Device: multiple breath washout test (MBW)
Device: impulse oscillometry (IOS)
Device: body plethysmography (BP)
Device: quantitative computed tomography (qCT)
ultra-low-dose qCT


Outcome Measures
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Primary Outcome Measures :
  1. correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT [ Time Frame: 2 weeks ]
  2. correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT [ Time Frame: 2 weeks ]
  3. correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with indication for routine lung function testing and computed tomography
Criteria

Inclusion Criteria:

  • known or suspected pulmonary lung disease
  • indication for computed tomography

Exclusion Criteria:

  • pregnancy
  • inability to participate
Contacts and Locations
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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): NCT02826265


Contacts
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Contact: Frederik Trinkmann, Dr. +496213833879 frederik.trinkmann@umm.de

Locations
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Germany
Universitätsmedizin Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Trinkmann, Dr.    +49    frederik.trinkmann@umm.de   
Principal Investigator: Frederik Trinkmann, Dr.         
Principal Investigator: Joachim Saur, Prof. Dr.         
Principal Investigator: Thomas Henzler, Prof. Dr.         
Sponsors and Collaborators
Universitätsmedizin Mannheim
More Information
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Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02826265    
Other Study ID Numbers: MBW-qCT
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Asthma
Respiratory Tract Diseases
Chronic Disease
 Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases