CLE During Exercise Testing in Asthma (CLEtesting)

Continuous Laryngoscopy During Exercise Testing in Patients With Asthma

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.

Study Overview

• Status: Withdrawn
• Conditions: Larynx; Obstruction; Vocal Cord Dysfunction
• Intervention / Treatment: Diagnostic test: Continuous laryngoscopy during exercise test

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Asthma; Asthma and symptomatic during exercise	Diagnostic test: Continuous laryngoscopy during exercise test; Continuous laryngoscopy during exercise test
Other: Severe asthma; Severe asthma and symptomatic during exercise	Diagnostic test: Continuous laryngoscopy during exercise test; Continuous laryngoscopy during exercise test

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction
• Other Study ID Numbers: HUS/886/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No