Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma

Haukeland University Hospital

Status: Completed

Conditions: Vocal Cord Dysfunction; Asthma Chronic

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

Study type: Observational

Funder types: Other

Identifiers

NCT04593394

108266

Details and patient eligibility

About

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, .

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

116 participants in 3 patient groups

Severe asthma

Description:

Gina-guidlines treatment-step 5

Treatment:

Diagnostic Test: Continous laryngoscopy exercise test

Diagnostic Test: Overnight respiratory polygraphy

Mild-moderate asthma

Description:

Gina-guidlines treatment-step 1-4

Treatment:

Diagnostic Test: Continous laryngoscopy exercise test

Diagnostic Test: Overnight respiratory polygraphy

Subjects without asthma

Description:

Matches control-group without asthma

Treatment:

Diagnostic Test: Continous laryngoscopy exercise test

Diagnostic Test: Overnight respiratory polygraphy