NCT03550456

Diagnostics and Quality of Life With EIA and EILO

Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the quality of life of subjects suffering from dyspnoea while exercising and quantify the number of diagnoses of Exercise induced Asthma (EIA) and Exercise induced laryngeal obstruction (EILO) in our outpatient clinic using an exercise-challenge in a cold-chamber and an exercise-challenge with continuous laryngoscopy.

Detailed description

In this study investigators want to characterize and investigate the quality of life of all patients consulting the outpatient clinic for pediatric pulmonology suffering from dyspnoea while exercising. Besides standard diagnostics (bodyplethysmograph, spirometry, exhaled NO, skin prick test) subjects will take part in an exercise-challenge in a cold chamber at 2-4°C. Subjects showing symptoms of exercise-induced asthma will get a treatment with ICS/LABA for six weeks. All Patients should fill out a symptom diary. On suspicion of an EILO, subjects not showing symptoms in the first exercise-challenge in the cold chamber and all subjects without improvement after EIA treatment will take part in a second exercise-challenge in the cold chamber with continuous laryngoscopy. If EILO is proved by laryngoscopy, speech therapy is recommended. To investigate the symptoms and the quality of life of these patients, all patients and there parents should answer symptom and quality of life questionnaires (Child Behavior Checklist (CBCL/4-18), Youth Self-Report (YSR 11-18), Asthma Control Test, (ACT) Dyspnea Index (DI)) at every visit. There are yearly follow ups of these patients for five years in order to collect long-range prognosis.

Conditions

• Exercise Induced Asthma
• Exercise Induced Pharyngeal Collapse

Interventions

Type	Name	Description
OTHER	ECC	Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
OTHER	ECC with CLE	Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
OTHER	Speech therapy	Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-06-08
• Last updated: 2020-07-30

Locations

1 site across 1 country: Germany