Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-03-01
2021-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Asthma
Asthma and symptomatic during exercise
Continuous laryngoscopy during exercise test
Continuous laryngoscopy during exercise test
Severe asthma
Severe asthma and symptomatic during exercise
Continuous laryngoscopy during exercise test
Continuous laryngoscopy during exercise test
Interventions
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Continuous laryngoscopy during exercise test
Continuous laryngoscopy during exercise test
Eligibility Criteria
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Inclusion Criteria
* symptomatic during exercise
Exclusion Criteria
* respiratory infection in the last 14 days
* asthma excacerbation in the last 14 days
* unstable cardiovascular disease
* bleeding disorder
* anticoagulant treatment (other than ASA)
18 Years
75 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Paula Kauppi, MD, PhD
MD, PhD, Chief Specialist
Principal Investigators
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Paula Kauppi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital
Helsinki, , Finland
Countries
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References
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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.
Bardin 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.
Other Identifiers
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HUS/886/2018
Identifier Type: -
Identifier Source: org_study_id
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