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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; COPD GOLD I to IV; Asthma GINA 1 to 4
• Intervention / Treatment: Device: Low frequency ultrasound spectroscopy after broncholysis

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Fraunhofer ITEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low frequency ultrasound spectroscopy; Low frequency ultrasound spectroscopy after broncholysis	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Collaborators: Institute for Pharmacology and Toxicology, RWTH Aachen

Publications and helpful links

General Publications

• Morenz K, Biller H, Wolfram F, Leonhadt S, Ruter D, Glaab T, Uhlig S, Hohlfeld JM. Detection of air trapping in chronic obstructive pulmonary disease by low frequency ultrasound. BMC Pulm Med. 2012 Mar 16;12:8. doi: 10.1186/1471-2466-12-8.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (ESTIMATE): March 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 23, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 08/10 Pabes