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

NCT02826265 | Unknown DMC

• 1 other identifier: MBW-qCT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchial Asthma; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (3)

• correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT

  2 weeks

• correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT

  2 weeks

• correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT

  2 weeks

Study Arms (1)

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)

Interventions

multiple breath washout test (MBW) DEVICE

pulmonary disease

impulse oscillometry (IOS) DEVICE

pulmonary disease

body plethysmography (BP) DEVICE

pulmonary disease

quantitative computed tomography (qCT) DEVICE

ultra-low-dose qCT

pulmonary disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with indication for routine lung function testing and computed tomography

You may qualify if:

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

You may not qualify if:

• pregnancy
• inability to participate

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Lung Diseases, Interstitial

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Central Study Contacts

Frederik Trinkmann, Dr.

CONTACT

+496213833879; frederik.trinkmann@umm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)