CLE During Exercise Testing in Asthma

Not Applicable

Withdrawn

• Conditions: Larynx; Obstruction; Vocal Cord Dysfunction
• Interventions: Diagnostic Test: Continuous laryngoscopy during exercise test

• Registration Number: NCT04168671
• Lead Sponsor: Helsinki University Central Hospital

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

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe asthma	Continuous laryngoscopy during exercise test	Severe asthma and symptomatic during exercise
Asthma	Continuous laryngoscopy during exercise test	Asthma and symptomatic during exercise

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland