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CompletedNCT04593394Updated Nov 21, 2025

Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma

An observational study in Asthma Chronic and Vocal Cord Dysfunction, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
116
Ages
18 Years to 70 Years
Sex
All
01

Study 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, .

Read the 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.

02

Conditions studied

  • Asthma Chronic
  • Vocal Cord Dysfunction

Keywords

  • Inducible laryngeal dysfunction, Severe asthma,
03

In context

Vocal Cord Dysfunction

18 studies on the registry are indexed under Vocal Cord Dysfunction; 4 are open to participants now.

Browse Vocal Cord Dysfunction studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
116 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testContinous 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 testOvernight 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

  2. 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.

    Time frame: One year

Secondary outcomes

  1. 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

    Time frame: One year

  2. 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)

    Time frame: One year

  3. 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.

    Time frame: One year

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

    Changes of 0.5 at m-AQLQ are considered a clinical relevant change

    Time frame: One year

07

Study locations

1 site
  • Haukeland University Hospital
    Bergen, 5021, Norway
08

References and documents

Publications

  • 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. PubMed 37328176 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04593394
Responsible party
Sponsor
First posted
Oct 20, 2020
Start date
Nov 1, 2020
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024
Last update
Nov 21, 2025

Study contacts

Sverre Lehmann, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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