CLE During Exercise Testing in Asthma (CLEtesting)
Primary Purpose
Larynx, Obstruction, Vocal Cord Dysfunction
Status
Withdrawn
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Continuous laryngoscopy during exercise test
Sponsored by
About this trial
This is an interventional diagnostic trial for Larynx
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)
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Asthma
Severe asthma
Arm Description
Asthma and symptomatic during exercise
Severe asthma and symptomatic during exercise
Outcomes
Primary Outcome Measures
Laryngeal obstruction
Semi-quantitative visual estimation of laryngeal obstruction in test
Secondary Outcome Measures
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.
Exercise capacity in CLE in asthma
Maximal work load in exercise test measured by W max 4 min
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)
Exercise induced lung function changes
Change from baseline FEV1 after the test
Full Information
NCT ID
NCT04168671
First Posted
April 23, 2019
Last Updated
July 1, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04168671
Brief Title
CLE During Exercise Testing in Asthma
Acronym
CLEtesting
Official Title
Continuous Laryngoscopy During Exercise Testing in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Coronavirus pandemia
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Larynx, Obstruction, Vocal Cord Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Asthma vs severe asthma
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthma
Arm Type
Other
Arm Description
Asthma and symptomatic during exercise
Arm Title
Severe asthma
Arm Type
Other
Arm Description
Severe asthma and symptomatic during exercise
Intervention Type
Diagnostic Test
Intervention Name(s)
Continuous laryngoscopy during exercise test
Intervention Description
Continuous laryngoscopy during exercise test
Primary Outcome Measure Information:
Title
Laryngeal obstruction
Description
Semi-quantitative visual estimation of laryngeal obstruction in test
Time Frame
From immediately before (-5 minutes) before the exercise test, during the test up to 30 minutes
Secondary Outcome Measure Information:
Title
Safety of CLE in asthma (Incidence of test-emergent adverse events)
Description
Incidence of test-emergent adverse events: nasal bleeding or pain, panic attack, bronchial obstruction.
Time Frame
From immediately before (-10 minutes) before the exercise test, during the test up to 30 minutes
Title
Exercise capacity in CLE in asthma
Description
Maximal work load in exercise test measured by W max 4 min
Time Frame
From 0 minutes before the exercise test and during the test up to 30 minutes
Title
Dyspnea in CLE in asthma
Description
Assessment of patient reported dyspnea in maximal exercise measured by scale from 0 to 10 (Borg's scale) (0 no symptoms - 10 maximal dyspnea)
Time Frame
From 0 minutes before the exercise test and during the test up to 30 minutes
Title
Exercise induced lung function changes
Description
Change from baseline FEV1 after the test
Time Frame
Immediately before test (0 minutes), and 10 minutes and 20 minutes after the test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Kauppi, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30908672
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.
Results Reference
background
PubMed Identifier
28664856
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.
Results Reference
background
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CLE During Exercise Testing in Asthma
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