CLE During Exercise Testing in Asthma

Larynx Clinical Trial

— CLEtesting  

Official title:

Continuous Laryngoscopy During Exercise Testing in Patients With Asthma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04168671
• Other study ID #: HUS/886/2018
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Larynx
• Obstruction
• Vocal Cord Dysfunction

Intervention

Diagnostic Test:
• Continuous laryngoscopy during exercise test
Continuous laryngoscopy during exercise test

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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