An observational study in Exercise Induced Asthma and Exercise Induced Pharyngeal Collapse, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Johann Wolfgang Goethe University Hospital · Observational
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.
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
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Patients from our outpatient clinic aged 8-18 years with exercise induced dyspnea and at least two training session per week.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: ECC · Other: ECC with CLE · Other: Speech therapy
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
Quality of life in subjects with exercise induced asthma and exercise induced laryngeal obstruction
The primary endpoint is the quality of life of all subjects with EIA and EILO assessed by questionnaires (Child Behavior Checklist (CBCL/4-18) for parents and Youth Self-Report (YSR 11-18) for adolescents) at the time of diagnosis and after therapy in accordance with the diagnosis with ICS/LABA combination or speech therapy. Both questionnaires are almost identical and contain 120 items (CBCL/4-18) and 119 items (YSR), respectively, in eight different categories: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, and aggressive behavior. Answers to each item are coded on a 3-point Likert-scale, 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. Raw scores are transformed into T-scores to allow comparison with children from the same gender and age.
Time frame: 5 years
Symptoms of EIA and EILO
Comparison of symptom score ACT and DI between EIA and EILO.
Time frame: 5 years
Prevalence
Patients suffering from exercise induced dyspnea are evaluated of prevalence of EIA-, EILO and combinations of EIA+EILO.
Time frame: 1 year
Speech therapy
Success monitoring of speech therapy of EILO or combination of EIA+EILO on the basis of a survey concerning the quality of life and symptoms.
Time frame: 5 years
Carbon dioxide
Changes in the concentration of carbon dioxide in the blood by capillary blood gas analysis before and after the exercise challenge in a cold chamber and before and after CLE diagnostics.
Time frame: 5 years
Ran from Nov 2018 to primary completion in Dec 2019, 13 months.
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