CLE During Exercise Testing in Asthma

Study Overview
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Brief Summary
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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
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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

Official Title
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Continuous Laryngoscopy During Exercise Testing in Patients With Asthma

Conditions
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Larynx, Obstruction, Vocal Cord Dysfunction

Intervention / Treatment
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* Diagnostic Test: Continuous laryngoscopy during exercise test


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Asthma vs severe asthma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Asthma<br>Asthma and symptomatic during exercise | Diagnostic Test: Continuous laryngoscopy during exercise test<br>* Continuous laryngoscopy during exercise test<br>|
| Other: Severe asthma<br>Severe asthma and symptomatic during exercise | Diagnostic Test: Continuous laryngoscopy during exercise test<br>* Continuous laryngoscopy during exercise test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngeal obstruction | Semi-quantitative visual estimation of laryngeal obstruction in test | From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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) | 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 | Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test |