Clinical trial NCT04168671: CLE During Exercise Testing in Asthma
Official title: Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Larynx
Obstruction
Vocal Cord Dysfunction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Asthma vs severe asthma
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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)

Primary outcomes:
measure: Laryngeal obstruction
timeFrame: From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes
Secondary outcomes:
measure: Safety of CLE in asthma (Incidence of test-emergent adverse events)
timeFrame: From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes
measure: Exercise capacity in CLE in asthma
timeFrame: From 0 minutes before the exercise test and during the test up to 30 minutes
measure: Dyspnea in CLE in asthma
timeFrame: From 0 minutes before the exercise test and during the test up to 30 minutes
measure: Exercise induced lung function changes
timeFrame: Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Paula Kauppi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.