LarynxCLEtestingNCT04168671
CLE During Exercise Testing in Asthma
A study testing Continuous laryngoscopy during exercise test in people with Larynx and Obstruction, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose is to assess visualize the level of laryngeal obstruction and vocal cord dysfunction and to obtain more information on causes for dyspnea in asthma and severe asthma and to assess safety of CLE in patients with asthma and with severe asthma. Patients are examined if symptomatic during exercise. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Larynx, Obstruction, Vocal Cord Dysfunction
- What is being tested?
- Continuous laryngoscopy during exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2019to 31 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician diagnosed asthma
- symptomatic during exercise
Who cannot join
- FEV1 <60%
- respiratory infection in the last 14 days
- asthma excacerbation in the last 14 days
- unstable cardiovascular disease
- bleeding disorder
- anticoagulant treatment (other than ASA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
The purpose is to assess visualize the level of laryngeal obstruction and vocal cord dysfunction and to obtain more information on causes for dyspnea in asthma and severe asthma and to assess safety of CLE in patients with asthma and with severe asthma. Patients are examined if symptomatic during exercise.
Read the detailed description
- Questionnaires to assess breathlessness before the test.
- CLE on ergometer bicycle using any laryngoscopy setup
- Ergometry with spirometry tests with ECG, oxygen saturation, blood pressure, inspiratory and expiratory flow volume curves, bronchodilator after the exercise test
- Work load of 40W with 3 minutes intervals and increase by 40W in women. In men, work load of 50W with 3 minutes intervals and increase by 50W starting from 50W. In elderly and more severely disease work load of 30W with 3 minutes intervals and increase by 30W.
- Recording of dyspnoea, leg fatigue and chest discomfort
- Assessment of asthma by asthma control test, spirometry, exhaled NO measurements.
- Severe asthma group: physician-diagnosed asthma, moderate-high dose inhaled glucorticoid steroids and a second controller drug, exacerbations and per oral glucocorticoid steroid courses at least 2 in the past 12 months and/or 50% of the past 12 months on per oral glucocorticoidsteroids
- Conditions
- Larynx, Obstruction, Vocal Cord Dysfunction
- Being tested
- Continuous laryngoscopy during exercise test
- Medical subject headings
- Laryngeal Diseases, Bites and Stings, Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous laryngoscopy during exercise testDiagnostic test
Continuous laryngoscopy during exercise test
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Other | Asthma and symptomatic during exercise Receives: Diagnostic Test: Continuous laryngoscopy during exercise test |
| Severe asthma | Other | Severe asthma and symptomatic during exercise Receives: Diagnostic Test: Continuous laryngoscopy during exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal obstruction
Semi-quantitative visual estimation of laryngeal obstruction in test
Measured: From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes
Secondary outcomes (4)
Safety of CLE in asthma (Incidence of test-emergent adverse events)
Incidence of test-emergent adverse events: nasal bleeding or pain, panic attack, bronchial obstruction.
Measured: From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes
Exercise capacity in CLE in asthma
Maximal work load in exercise test measured by W max 4 min
Measured: From 0 minutes before the exercise test and during the test up to 30 minutes
Dyspnea in CLE in asthma
Assessment of patient reported dyspnea in maximal exercise measured by scale from 0 to 10 (Borg's scale) (0 no symptoms - 10 maximal dyspnea)
Measured: From 0 minutes before the exercise test and during the test up to 30 minutes
Exercise induced lung function changes
Change from baseline FEV1 after the test
Measured: Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Coronavirus pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LarynxStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Asthma vs severe asthma
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Kauppi, MD, PhD, Helsinki University Central Hospital
- Investigators
- Paula Kauppi, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168671
- Sponsor's protocol ID
- HUS/886/2018
- Acronym
- CLEtesting
- Status last verified
- Jul 2022
- First submitted
- 23 Apr 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawlor C, Smithers CJ, Hamilton T, Baird C, Rahbar R, Choi S, Jennings R. Innovative management of severe tracheobronchomalacia using anterior and posterior tracheobronchopexy. Laryngoscope. 2020 Feb;130(2):E65-E74. doi: 10.1002/lary.27938. Epub 2019 Mar 25.
PubMed 30908672Bardin PG, Low K, Ruane L, Lau KK. Controversies and conundrums in vocal cord dysfunction. Lancet Respir Med. 2017 Jul;5(7):546-548. doi: 10.1016/S2213-2600(17)30221-7. No abstract available.
PubMed 28664856
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
- ClinicalTrials.gov ID
- NCT04168671
- Acronym / sponsor ID
- CLEtesting / HUS/886/2018
- Conditions
- Larynx, Obstruction, Vocal Cord Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Coronavirus pandemia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- 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.
The purpose is to assess visualize the level of laryngeal obstruction and vocal cord dysfunction and to obtain more information on causes for dyspnea in asthma and severe asthma and to assess safety of CLE in patients with asthma and with severe asthma. Patients are examined if symptomatic during exercise.
Detailed description
- Questionnaires to assess breathlessness before the test.
- CLE on ergometer bicycle using any laryngoscopy setup
- Ergometry with spirometry tests with ECG, oxygen saturation, blood pressure, inspiratory and expiratory flow volume curves, bronchodilator after the exercise test
- Work load of 40W with 3 minutes intervals and increase by 40W in women. In men, work load of 50W with 3 minutes intervals and increase by 50W starting from 50W. In elderly and more severely disease work load of 30W with 3 minutes intervals and increase by 30W.
- Recording of dyspnoea, leg fatigue and chest discomfort
- Assessment of asthma by asthma control test, spirometry, exhaled NO measurements.
- Severe asthma group: physician-diagnosed asthma, moderate-high dose inhaled glucorticoid steroids and a second controller drug, exacerbations and per oral glucocorticoid steroid courses at least 2 in the past 12 months and/or 50% of the past 12 months on per oral glucocorticoidsteroids
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Asthma vs severe asthma
| Arm | Type | Receives |
|---|---|---|
| Asthma | Other | Diagnostic Test: Continuous laryngoscopy during exercise testAsthma and symptomatic during exercise |
| Severe asthma | Other | Diagnostic Test: Continuous laryngoscopy during exercise testSevere asthma and symptomatic during exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physician diagnosed asthma
- symptomatic during exercise
Key exclusion criteria (6 listed)
- FEV1 <60%
- respiratory infection in the last 14 days
- asthma excacerbation in the last 14 days
- unstable cardiovascular disease
- bleeding disorder
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 |
|---|---|---|
| Continuous laryngoscopy during exercise testContinuous laryngoscopy during exercise test | Diagnostic test | Asthma, Severe asthma |
Primary outcome
Laryngeal obstruction
Time frame: From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes
Semi-quantitative visual estimation of laryngeal obstruction in test
4 secondary outcomes
Safety of CLE in asthma (Incidence of test-emergent adverse events)
Time frame: From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes
Exercise capacity in CLE in asthma
Time frame: From 0 minutes before the exercise test and during the test up to 30 minutes
Dyspnea in CLE in asthma
Time frame: From 0 minutes before the exercise test and during the test up to 30 minutes
Exercise induced lung function changes
Time frame: Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 30908672Lawlor C, Smithers CJ, Hamilton T, Baird C, Rahbar R, Choi S, Jennings R. Innovative management of severe tracheobronchomalacia using anterior and posterior tracheobronchopexy. Laryngoscope. 2020 Feb;130(2):E65-E74. doi: 10.1002/lary.27938. Epub 2019 Mar 25.
- Background: PubMed 28664856Bardin PG, Low K, Ruane L, Lau KK. Controversies and conundrums in vocal cord dysfunction. Lancet Respir Med. 2017 Jul;5(7):546-548. doi: 10.1016/S2213-2600(17)30221-7. No abstract available.
- Individual participant dataSharing planned: No
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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.
Paula Kauppi, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous laryngoscopy during exercise test in people with Larynx and Obstruction, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 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: withdrawn, as of the sponsor's last update on 7 Jul 2022. 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 Finland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Laryngeal obstruction (time frame: From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes). 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 NCT04168671, which also lists 2 linked publications.
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 7 Jul 2022.