MRI study to investigate lung diseases (COPD and Asthma)

Conditions: The study is a diagnostic pilot study on COPD and Asthma patients
MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-021782-70-DE

Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Group 1: COPD: adults > 40years and < 70 years, 40 = FEV1 = 70%, smokers or former smokers

Group2. Asthma: adults >18 years and < 70years, FEV1 = 40%, verfified diagnosis of asthma (DGP) for at least 6 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

pregnacy
instable clinical status
MRI contraindications. metallic implants, claustrophobia
myocardial infarctus or cerebrovascular insult during the last 6 weeks
other acute lung diease within the last 6 weeks prior to the first visit
exacerbations during the last 6 months
renal dysfunction (gfr<60mL/min)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to investigate the He-MRI parameters in comparison with proton-MRI und pulmonary function tests in two patient groups and the change of these parameters after 1 year (including the effect of a bronchodilator);Secondary Objective: The secondary objective is to investigate the safety of helium-3 and the correlation between the different methods.;Primary end point(s): disease specific findings: He-MRI prior to and after bronchodilation;Timepoint(s) of evaluation of this end point: After completion of the first examination and after completion of the second examination of all patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlation of MRI parameters and lung function parameters;Timepoint(s) of evaluation of this end point: After completion of the first examination and after completion of the second examination of all patients