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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

March 3, 2010
June 23, 2011
February 2010
March 2010   (final data collection date for primary outcome measure)
• 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 ]
Same as current
Complete list of historical versions of study NCT01080924 on ClinicalTrials.gov Archive Site
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Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound
Not Provided

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy Volunteers
  • COPD GOLD I to IV
  • Asthma GINA 1 to 4
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.
Experimental: Low frequency ultrasound spectroscopy
Low frequency ultrasound spectroscopy after broncholysis
Intervention: Device: Low frequency ultrasound spectroscopy after broncholysis
Morenz K, Biller H, Wolfram F, Leonhadt S, Rüter 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01080924
08/10 Pabes
No
Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
Fraunhofer-Institute of Toxicology and Experimental Medicine
Institute for Pharmacology and Toxicology, RWTH Aachen
Principal Investigator: Jens Hohlfeld, Prof. Dr. Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer-Institute of Toxicology and Experimental Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP