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

This study has been completed.
Sponsor:
Collaborator:
Institute for Pharmacology and Toxicology, RWTH Aachen
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01080924
First received: March 3, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Healthy Volunteers
COPD GOLD I to IV
Asthma GINA 1 to 4
Device: Low frequency ultrasound spectroscopy after broncholysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • • 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 [ Time Frame: 10 minutes post broncholysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01080924

Locations
Germany
Fraunhofer ITEM
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Institute for Pharmacology and Toxicology, RWTH Aachen
Investigators
Principal Investigator: Jens Hohlfeld, Prof. Dr. Fraunhofer Institute for Toxicology and Experimental Medicine
  More Information

No publications provided by Fraunhofer-Institute of Toxicology and Experimental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01080924     History of Changes
Other Study ID Numbers: 08/10 Pabes
Study First Received: March 3, 2010
Last Updated: June 23, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Staatliches Gewerbeaufsichtsamt, Hannover

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014