Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound (Pabes)
This study has been completed.
Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
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
| Tracking Information | |||||
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| First Received Date ICMJE | March 3, 2010 | ||||
| Last Updated Date | June 23, 2011 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
• 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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01080924 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Low frequency ultrasound spectroscopy
Low frequency ultrasound spectroscopy after broncholysis
Intervention: Device: Low frequency ultrasound spectroscopy after broncholysis |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01080924 | ||||
| Other Study ID Numbers ICMJE | 08/10 Pabes | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine | ||||
| Study Sponsor ICMJE | Fraunhofer-Institute of Toxicology and Experimental Medicine | ||||
| Collaborators ICMJE | Institute for Pharmacology and Toxicology, RWTH Aachen | ||||
| Investigators ICMJE |
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| Information Provided By | Fraunhofer-Institute of Toxicology and Experimental Medicine | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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