Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma
NCT ID: NCT04593394
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
116 participants
OBSERVATIONAL
2020-11-01
2024-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The second part will be a longitudinally observational study study following participants for one year after the cross-sectional study. The Maat-scores ILO-symptoms and asthma-outcomes longitudinally will be evaluated, .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CLE During Exercise Testing in Asthma
NCT04168671
Diagnostics and Quality of Life With EIA and EILO
NCT03550456
Prevalence of EILO Among Children With Asthma
NCT06480084
Longitudinal Observational Study of Severe Asthma
NCT01780142
Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
NCT02537691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The prevalence of ILO in asthmatic patients will be assesed by preforming a CLE-test twice in all participants at baseline and again after one year. Participant will be given visual feedback and instructed in breathing techniques. Others common comorbidities will be assessed by questionnaires and clinical interview. All patients with asthma will have a respiratory polygraph recording.
Changes in ILO-symptoms and asthma-symptoms and outcomes will be assessed after 1 year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Severe asthma
Gina-guidlines treatment-step 5
Continous laryngoscopy exercise test
Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored
Overnight respiratory polygraphy
Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
Mild-moderate asthma
Gina-guidlines treatment-step 1-4
Continous laryngoscopy exercise test
Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored
Overnight respiratory polygraphy
Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
Subjects without asthma
Matches control-group without asthma
Continous laryngoscopy exercise test
Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored
Overnight respiratory polygraphy
Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Continous laryngoscopy exercise test
Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored
Overnight respiratory polygraphy
Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with mild-moderate well-treated asthma (GINA step 1-4)
* Agroup of age- and gender matched control subjects without asthma also aged 18- 70.
* The patients must have had a stable disease the last one month before performing the CLE-test
Exclusion Criteria
* No known cancer in the lung-head-neck
* No known vocal cord pathology.
* No history of life-threatening asthma required hospitalization.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sverre Lehmann, PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland University Hospital
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rogde AJ, Lehmann S, Halvorsen T, Clemm HH, Roksund OD, Hufthammer KO, Kvidaland HK, Vollsaeter M, Andersen TM. Prevalence and impact of exercise-induced laryngeal obstruction in asthma: a study protocol for a cross-sectional and longitudinal study. BMJ Open. 2023 Jun 16;13(6):e071159. doi: 10.1136/bmjopen-2022-071159.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
108266
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.