Open monocentric clinical pilot study in COPD und Asthma patients to investigate static as wellas dynamic ventilation, intrapulmonary ADC and pO2 using helium-3-MRI after inhalation ofhyperpolarised helium-3 gas; a comparison with pulmonary function tests und H-MRI (long-termobservation).
Phase 2
- Conditions
- J44.9J45Chronic obstructive pulmonary disease, unspecifiedAsthma
- Registration Number
- DRKS00003217
- Lead Sponsor
- Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie der Universitätsmedizin Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Group 1: COPD: adults > 40years and < 70 years, verified diagnosis of asthma, 40 = FEV1 = 70%, smokers or former smokers, no exacerbations during the last 2 months
Group2: Asthma: adults >18 years and < 70years, FEV1 = 40%, verfified diagnosis of asthma (DGP) for at
least 6 months
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 2 months
renal dysfunction (gfr<60mL/min)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease specific findings: He-MRI prior to and after bronchodilation at the study start and after 1 year.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of helium-3