- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593394
Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma
Inducible Laryngeal Obstruction in Severe Asthma
The first part will be a comparative cross-sectional study to identify the frequency of ILO and other comorbidites among participants with asthma compared to a group of reference subjects without asthma, matched for age- and gender and race.
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, .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inducible laryngeal obstruction (ILO) is characterized by inappropriate closure of the structures of the larynx causing reduced airflow. The symptoms are breathing difficulties that resemble those seen in asthmatic patients, such as dyspnea, coughing and stridor. ILO may be diagnosed by the continuous laryngoscopy during exercise test (CLE-test), where the larynx is visualized live on video as the patient runs to exhaustion on a treadmill whilst having a laryngoscope placed through the nose.
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5021
- Haukeland University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with severe asthma (GINA 5)
- 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 have underlying neurologic disease.
- No known cancer in the lung-head-neck
- No known vocal cord pathology.
- No history of life-threatening asthma required hospitalization.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe asthma
Gina-guidlines treatment-step 5
|
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 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
|
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 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
|
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 is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of ILO in the participants
Time Frame: One year
|
Continues during exercise(CLE)-test score at 2 or more at glottis or supraglottic level (Score range 0 minimum -3 maximum) 3 is full closure, 0 i open.
|
One year
|
Changes in continues during exercise (CLE-)-test score
Time Frame: One year
|
The absolute change from baseline CLE-score (Score range 0 minimum -3 maximum).
3 is full closure in larynx, 0 is open.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prevalence of OSA in asthma patients with ILO.
Time Frame: One year
|
Prevalence of mild ( apnea-hypopnea index (AHI )5-15 ) moderat (AHI 15-30) and severe (AHI > 30 )OSA in participents with asthma and ILO
|
One year
|
Changes in asthma-controll score (ACT)
Time Frame: One year
|
Changes of 3 points of ACT-score are considered a clinical relevant change, score (score range minimum 5, maximum 25)
|
One year
|
Number of asthma-exercabations
Time Frame: One year
|
Annual asthma exacerbation rate and the precentage of patients with at least one asthma exacerbation.
Asthma exacerbations are defined as worsening of asthma symptoms, and in participants on stable regimen with oral glucocorticoids, a doubling of the dose for 3 or more days or the use of systemic glucocorticoids for at least 3 days or beeing hospitalized.
|
One year
|
Changes in mini-Asthma quality of life (m-AQLQ)
Time Frame: One year
|
Changes of 0.5 at m-AQLQ are considered a clinical relevant change
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sverre Lehmann, PhD, Haukeland University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108266
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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