CLE During Exercise Testing in Asthma

NCT ID: NCT04168671

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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

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* 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

Conditions

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Larynx Obstruction Vocal Cord Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Asthma vs severe asthma
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Asthma

Asthma and symptomatic during exercise

Group Type OTHER

Continuous laryngoscopy during exercise test

Intervention Type DIAGNOSTIC_TEST

Continuous laryngoscopy during exercise test

Severe asthma

Severe asthma and symptomatic during exercise

Group Type OTHER

Continuous laryngoscopy during exercise test

Intervention Type DIAGNOSTIC_TEST

Continuous laryngoscopy during exercise test

Interventions

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Continuous laryngoscopy during exercise test

Continuous laryngoscopy during exercise test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paula Kauppi, MD, PhD

MD, PhD, Chief Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Kauppi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 30908672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28664856 (View on PubMed)

Other Identifiers

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HUS/886/2018

Identifier Type: -

Identifier Source: org_study_id

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