CLE During Exercise Testing in Asthma (CLEtesting)

Helsinki University Central Hospital (HUCH)

Status: Withdrawn

Conditions: Larynx; Obstruction; Vocal Cord Dysfunction

Treatments: Diagnostic Test: Continuous laryngoscopy during exercise test

Study type: Interventional

Funder types: Other

Identifiers

NCT04168671

HUS/886/2018

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Asthma

Other group

Description:

Asthma and symptomatic during exercise

Treatment:

Diagnostic Test: Continuous laryngoscopy during exercise test

Severe asthma

Other group

Description:

Severe asthma and symptomatic during exercise

Treatment:

Diagnostic Test: Continuous laryngoscopy during exercise test