EUCTR2010-021782-70-DE
Active, not recruiting
Not Applicable
Open monocentric clinical pilot study in COPD und Asthma patients to investigate static as well as dynamic ventilation, intrapulmonary ADC and pO2 using helium-3-MRI after inhalation of hyperpolarised helium-3 gas; a comparison with pulmonary function tests und H-MRI (long-term observation) - COALA-HE
niversitätsmedizin der Johannes Gutenberg-Universität Mainz0 sites24 target enrollmentNovember 25, 2010
ConditionsThe study is a diagnostic pilot study on COPD and Asthma patientsMedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The study is a diagnostic pilot study on COPD and Asthma patients
- Sponsor
- niversitätsmedizin der Johannes Gutenberg-Universität Mainz
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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)
Outcomes
Primary Outcomes
Not specified
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