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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low frequency ultrasound spectroscopy

Low frequency ultrasound spectroscopy after broncholysis

Group Type EXPERIMENTAL

Low frequency ultrasound spectroscopy after broncholysis

Intervention Type DEVICE

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.

Interventions

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Low 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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes