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

Healthy Volunteers Clinical Trial

— Pabes  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080924
• Other study ID #: 08/10 Pabes
• Status: Completed
• Phase: N/A
• First received: March 3, 2010
• Last updated: June 23, 2011
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and InformationGermany: Staatliches Gewerbeaufsichtsamt, Hannover
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma GINA 1 to 4
• COPD GOLD I to IV
• Healthy Volunteers
• Lung Diseases, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Fraunhofer ITEM	Hannover	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Fraunhofer-Institute of Toxicology and Experimental Medicine	Institute for Pharmacology and Toxicology, RWTH Aachen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No