Healthy VolunteersPabesNCT01080924
Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound
A study testing Low frequency ultrasound spectroscopy after broncholysis in people with Healthy Volunteers and COPD GOLD I to IV, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, COPD GOLD I to IV, Asthma GINA 1 to 4
- What is being tested?
- Low frequency ultrasound spectroscopy after broncholysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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)
Show all 9Show fewer
- BMI ≤ 30 kg/m2
- Able and willing to give written informed consent
- Available to complete all study measurements
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteers, COPD GOLD I to IV, Asthma GINA 1 to 4
- Being tested
- Low frequency ultrasound spectroscopy after broncholysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency ultrasound spectroscopy after broncholysisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low frequency ultrasound spectroscopy | Experimental | Low frequency ultrasound spectroscopy after broncholysis Receives: Device: Low frequency ultrasound spectroscopy after broncholysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 10 minutes post broncholysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University
- Investigators
- Jens Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080924
- Sponsor's protocol ID
- 08/10 Pabes
- Acronym
- Pabes
- Status last verified
- Jun 2011
- First submitted
- 3 Mar 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22424178
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound
- ClinicalTrials.gov ID
- NCT01080924
- Acronym / sponsor ID
- Pabes / 08/10 Pabes
- Conditions
- Healthy Volunteers, COPD GOLD I to IV, Asthma GINA 1 to 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- RWTH Aachen University
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low frequency ultrasound spectroscopy | Experimental | Device: Low frequency ultrasound spectroscopy after broncholysisLow frequency ultrasound spectroscopy after broncholysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • 18 - 70 years
Key exclusion criteria (6 listed)
- • medical conditions which prohibit the use of salbutamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low frequency ultrasound spectroscopy after broncholysisLow 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. | Device | Low frequency ultrasound spectroscopy |
Primary outcome
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Derived from this study: PubMed 22424178Morenz 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.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Hohlfeld, Prof. Dr. principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency ultrasound spectroscopy after broncholysis in people with Healthy Volunteers and COPD GOLD I to IV, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.