Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound

Study Overview
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Brief Summary
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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.

Conditions
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COPD GOLD I to IV, Healthy Volunteers, Asthma GINA 1 to 4

Intervention / Treatment
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* Device: Low frequency ultrasound spectroscopy after broncholysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low frequency ultrasound spectroscopy<br>Low frequency ultrasound spectroscopy after broncholysis | Device: Low frequency ultrasound spectroscopy after broncholysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |