Asthma ChronicNCT04593394
Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma
An observational study of Asthma Chronic and Vocal Cord Dysfunction, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma Chronic, Vocal Cord Dysfunction
- What is being tested?
- Continous laryngoscopy exercise test and Overnight respiratory polygraphy
- How many people
- 116 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2020to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, .
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.
- Conditions
- Asthma Chronic, Vocal Cord Dysfunction
- Being tested
- Continous laryngoscopy exercise test, Overnight respiratory polygraphy
- Keywords
- Inducible laryngeal dysfunction, Severe asthma,
- Medical subject headings
- Vocal Cord Dysfunction, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous laryngoscopy exercise testDiagnostic 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 polygraphyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Severe asthma | Gina-guidlines treatment-step 5 Receives: Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy | |
| Mild-moderate asthma | Gina-guidlines treatment-step 1-4 Receives: Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy | |
| Subjects without asthma | Matches control-group without asthma Receives: Diagnostic Test: Continous laryngoscopy exercise test; Diagnostic Test: Overnight respiratory polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year
Secondary outcomes (4)
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
Measured: 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)
Measured: 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.
Measured: One year
Changes in mini-Asthma quality of life (m-AQLQ)
Changes of 0.5 at m-AQLQ are considered a clinical relevant change
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Nov 2020
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma ChronicStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sverre Lehmann, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593394
- Sponsor's protocol ID
- 108266
- Status last verified
- May 2025
- First submitted
- 13 Oct 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducible Laryngeal Obstruction in Severe Asthma
- ClinicalTrials.gov ID
- NCT04593394
- Acronym / sponsor ID
- 108266
- Conditions
- Asthma Chronic, Vocal Cord Dysfunction
- Keywords
- Inducible laryngeal dysfunction, Severe asthma,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, .
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe asthma | – | Diagnostic Test: Continous laryngoscopy exercise test, Diagnostic Test: Overnight respiratory polygraphyGina-guidlines treatment-step 5 |
| Mild-moderate asthma | – | Diagnostic Test: Continous laryngoscopy exercise test, Diagnostic Test: Overnight respiratory polygraphyGina-guidlines treatment-step 1-4 |
| Subjects without asthma | – | Diagnostic Test: Continous laryngoscopy exercise test, Diagnostic Test: Overnight respiratory polygraphyMatches control-group without asthma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous laryngoscopy exercise testParticipants 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 | Mild-moderate asthma, Severe asthma, Subjects without asthma |
| Overnight respiratory polygraphyOvernight 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 | Diagnostic test | Mild-moderate asthma, Severe asthma, Subjects without asthma |
Primary outcome
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.
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.
4 secondary outcomes
The prevalence of OSA in asthma patients with ILO.
Time frame: One year
Changes in asthma-controll score (ACT)
Time frame: One year
Number of asthma-exercabations
Time frame: One year
Changes in mini-Asthma quality of life (m-AQLQ)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 37328176Rogde 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sverre Lehmann, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Chronic and Vocal Cord Dysfunction, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ILO in the participants (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.