Diagnostics and Quality of Life With EIA and EILO
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|ClinicalTrials.gov Identifier: NCT03550456|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment|
|Exercise Induced Asthma Exercise Induced Pharyngeal Collapse||Other: ECC Other: ECC with CLE Other: Speech therapy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2024|
ECC, ECC with CLE, speech therapy
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.
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.
- Quality of life in subjects with exercise induced asthma and exercise induced laryngeal obstruction [ Time Frame: 5 years ]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.
- Symptoms of EIA and EILO [ Time Frame: 5 years ]Comparison of symptom score ACT and DI between EIA and EILO.
- Prevalence [ Time Frame: 1 year ]Patients suffering from exercise induced dyspnea are evaluated of prevalence of EIA-, EILO and combinations of EIA+EILO.
- Speech therapy [ Time Frame: 5 years ]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.
- Carbon dioxide [ Time Frame: 5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550456
|Contact: Johannes Schulze, Assoc. Prof.||+49-69-6301 email@example.com|
|Contact: Melanie Dreßler, MD||+49-69-6301 firstname.lastname@example.org|
|Goethe University Hospital Frankfurt||Recruiting|
|Frankfurt, Hessen, Germany, 60590|
|Contact: Johannes Schulze, PD +49 69 6301 5732 email@example.com|
|Contact: Melanie Dressler, MD +49 69 6301 5732 firstname.lastname@example.org|
|Principal Investigator:||Johannes Schulze, Assoc. Prof.||Johann Wolfgang Goethe University Hospital|