Asthma GINA 1 to 4, COPD GOLD I to IV, Healthy Volunteers
Conditions
Brief summary
This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.
Interventions
DEVICELow frequency ultrasound spectroscopy after broncholysis
Low frequency ultrasound spectroscopy is a novel non-invasive approach to real-time diagnostics of the lungs. Low frequency ultrasound at 10 to 1000 kHz permits monitoring of the air and water contents of the human thorax.
Sponsors
Institute for Pharmacology and Toxicology, RWTH Aachen
Fraunhofer-Institute of Toxicology and Experimental Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* • 18 - 70 years * for the healthy cohort: * FEV1 \> 80 % pred, FEV1/FVC ≥ 70 % pred., no history of allergies or asthma * nonsmokers, with a history of less than 1 packyear having been nonsmokers for at least the last five years * for the COPD cohort: COPD GOLD I to IV according to current guidelines (2) * for the asthma cohort: history of asthma GINA I to IV according to current guidelines (3) * BMI ≤ 30 kg/m2 * Able and willing to give written informed consent * Available to complete all study measurements
Exclusion criteria
* • medical conditions which prohibit the use of salbutamol * recent exacerbation of COPD or asthma or lower respiratory tract infection (four weeks previous to informed consent visit) * past or present disease, which as judged by the investigator, may affect the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis) * history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment * risk of non-compliance with study procedures * suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • change of the difference of expiratory and inspiratory TOF Expectation: The difference of ex and inspiratory TOF should increase after broncholysis. A change above 10us will be considered significant | 10 minutes post broncholysis |
Countries
Germany
Outcome results
None listed