Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of life in subjects with exercise induced asthma and exercise induced laryngeal obstruction
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Speech therapy(5 years)
- Symptoms of EIA and EILO(5 years)
- Prevalence(1 year)
- Carbon dioxide(5 years)
Investigators
Johannes Schulze MD
Prof.
Johann Wolfgang Goethe University Hospital