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Clinical Trials/DRKS00003217
DRKS00003217Active, not recruitingPhase 2

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). - COALA-He

Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie der Universitätsmedizin Mainz0 sites12 target enrollmentStarted: August 22, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Enrollment
12

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomized controlled study
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 70 Years (—)
Sex
All

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

  • 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)

Investigators

Sponsor
Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie der Universitätsmedizin Mainz

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