Study Stopped
Coronavirus pandemia
CLE During Exercise Testing in Asthma
CLEtesting
Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 7, 2022
July 1, 2022
2.8 years
April 23, 2019
July 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Exercise capacity in CLE in asthma
From 0 minutes before the exercise test and during the test up to 30 minutes
Dyspnea in CLE in asthma
From 0 minutes before the exercise test and during the test up to 30 minutes
Exercise induced lung function changes
Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test
Study Arms (2)
Asthma
OTHERAsthma and symptomatic during exercise
Severe asthma
OTHERSevere asthma and symptomatic during exercise
Interventions
Continuous laryngoscopy during exercise test
Eligibility Criteria
You may qualify if:
- physician diagnosed asthma
- symptomatic during exercise
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Central Hospital
Helsinki, 00029, Finland
Related Publications (2)
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.
PMID: 30908672BACKGROUNDBardin 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.
PMID: 28664856BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula Kauppi, MD, PhD
Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Chief Specialist
Study Record Dates
First Submitted
April 23, 2019
First Posted
November 19, 2019
Study Start
March 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 7, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share