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: Active, not recruiting
• Conditions: Vocal Cord Dysfunction; Asthma Chronic
• Intervention / Treatment: Diagnostic test: Continous laryngoscopy exercise test; Diagnostic test: Overnight respiratory polygraphy

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: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The sample size of the cohort with severe asthma will be: All patients with severe asthma followed in our clinic for severe asthma estimated to be around 80 participants, of them, we hope to recruit at least 40 to perform the CLE-test, and we plan to recruit 40 participants with mild asthma and 40 age- and gender matched control subjects without asthma

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe asthma; Gina-guidlines treatment-step 5	Diagnostic test: 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; Diagnostic test: 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	Diagnostic test: 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; Diagnostic test: 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	Diagnostic test: 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; Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of ILO in the participants	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	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.	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)	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	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)	Changes of 0.5 at m-AQLQ are considered a clinical relevant change	One year

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Sverre Lehmann, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inducible laryngeal dysfunction, Severe asthma,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Laryngeal Diseases; Asthma; Vocal Cord Dysfunction
• Other Study ID Numbers: 108266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No