Larynx, Obstruction, Vocal Cord Dysfunction
Conditions
Brief 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.
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
Interventions
DIAGNOSTIC_TESTContinuous laryngoscopy during exercise test
Continuous laryngoscopy during exercise test
Sponsors
Helsinki University Central Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Asthma vs severe asthma
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* physician diagnosed asthma * symptomatic during exercise
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laryngeal obstruction | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of CLE in asthma (Incidence of test-emergent adverse events) | From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes | Incidence of test-emergent adverse events: nasal bleeding or pain, panic attack, bronchial obstruction. |
| Exercise capacity in CLE in asthma | From 0 minutes before the exercise test and during the test up to 30 minutes | Maximal work load in exercise test measured by W max 4 min |
| Dyspnea in CLE in asthma | From 0 minutes before the exercise test and during the test up to 30 minutes | Assessment of patient reported dyspnea in maximal exercise measured by scale from 0 to 10 (Borg's scale) (0 no symptoms - 10 maximal dyspnea) |
| Exercise induced lung function changes | Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test | Change from baseline FEV1 after the test |
Countries
Finland
Outcome results
None listed