Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma

NCT04593394 | Completed

• 1 other identifier: 108266
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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, .

Conditions

Asthma Chronic; Vocal Cord Dysfunction

Keywords

Inducible laryngeal dysfunction, Severe asthma,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The prevalence of OSA in asthma patients with ILO.

  One year

• Changes in asthma-controll score (ACT)

  One year

• Number of asthma-exercabations

  One year

• Changes in mini-Asthma quality of life (m-AQLQ)

  One year

Study Arms (3)

Severe asthma

Gina-guidlines treatment-step 5

Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy

Mild-moderate asthma

Gina-guidlines treatment-step 1-4

Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy

Subjects without asthma

Matches control-group without asthma

Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy

Interventions

Continous laryngoscopy exercise test DIAGNOSTIC_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

Mild-moderate asthma; Severe asthma; Subjects without asthma

Overnight respiratory polygraphy DIAGNOSTIC_TEST

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; Severe asthma; Subjects without asthma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 37328176 DERIVED

MeSH Terms

Conditions

Vocal Cord Dysfunction; Asthma

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sverre Lehmann, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-05

Locations

NO (1)