Diagnostics and Quality of Life With EIA and EILO

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Exercise Induced Asthma; Exercise Induced Pharyngeal Collapse

Treatments: Other: Speech therapy; Other: ECC with CLE; Other: ECC

Study type: Observational

Funder types: Other

Identifiers

NCT03550456

KGU-83/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written agreement
• age: >=8 and <= 18
• exercise induced dyspnea
• at least two training session per week
• lung function before physical exercise FVC >= 75% and FEV1 >= 70%

Exclusion criteria

• age <8 and >18
• lung function: forced vital capacity (FVC) < 75% and forced expiratory pressure in one second (FEV1) < 70%
• inability to understand the range oft the study
• chronic asthma with systemic cortisone therapy
• chronic asthma with high dose cortisone inhalation >500 micrograms fluticasone equivalent
• intake of long acting beta-agonists (LABA) 48 h before examination
• acute severe infection (pneumonia) within the last 4 weeks
• intake of leukotriene-antagonists 48h before examination
• other chronic diseases or infections (HIV, Tbc)
• pregnancy

Trial design

40 participants in 1 patient group

ECC, ECC with CLE, speech therapy

Description:

After the standard diagnostic (spirometry, body plethysmography, exhaled NO, skin prick test) all patients with dyspnea while exercising undergo exercise challenges in a cold chamber (ECC). In case of a positive reaction in the ECC the patients get asthma medication (ICS/LABA combination). Both groups negative and positive should fill out a symptom diary and the next visit will be booked 6 weeks later. If they still have dyspnea while exercising with ICS/LABA combination or hat a negative ECC the patients undergo an ECC with continuous laryngoscopy. In case of an EILO diagnosis patients will be sent to speech therapy and checked at a follow up visit. All patients and their parents should complete questionnaires for symptoms and quality of life at every visit.

Treatment:

Other: ECC with CLE

Other: ECC

Other: Speech therapy