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Completed

NCT Number: NCT01080924

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low frequency ultrasound spectroscopy after broncholysis

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.

Primary outcomes

  1. • 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

Sponsors and collaborators

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Other

Collaborators

  • RWTH Aachen University

Registry information

Acronym: Pabes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 5, 2010
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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