Clinical trial NCT03550456: Diagnostics and Quality of Life With EIA and EILO
Official title: Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Induced Asthma
Exercise Induced Pharyngeal Collapse
Keywords: Exercise Induced Asthma (EIA)
Exercise Induced Laryngeal Obstruction (EILO)
Quality of life
Exercise challenge in cold chamber (ECC)
Continous laryngoscopy while exercising (CLE)
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from our outpatient clinic aged 8-18 years with exercise induced dyspnea and at least two training session per week.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life in subjects with exercise induced asthma and exercise induced laryngeal obstruction
timeFrame: 5 years
Secondary outcomes:
measure: Symptoms of EIA and EILO
timeFrame: 5 years
measure: Prevalence
timeFrame: 1 year
measure: Speech therapy
timeFrame: 5 years
measure: Carbon dioxide
timeFrame: 5 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Johannes Schulze, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
citation: Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
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citation: Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
citation: Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
citation: Schulze J, Rosewich M, Dressler M, Riemer C, Rose MA, Zielen S. Bronchial allergen challenge using the Medicaid dosimeter. Int Arch Allergy Immunol. 2012;157(1):89-97. doi: 10.1159/000324473. Epub 2011 Sep 7.
citation: Schulze J, Voss S, Zissler U, Rose MA, Zielen S, Schubert R. Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge. Respir Res. 2012 Sep 19;13(1):78. doi: 10.1186/1465-9921-13-78.
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citation: Johansson H, Norlander K, Berglund L, Janson C, Malinovschi A, Nordvall L, Nordang L, Emtner M. Prevalence of exercise-induced bronchoconstriction and exercise-induced laryngeal obstruction in a general adolescent population. Thorax. 2015 Jan;70(1):57-63. doi: 10.1136/thoraxjnl-2014-205738. Epub 2014 Nov 7.
citation: Nielsen EW, Hull JH, Backer V. High prevalence of exercise-induced laryngeal obstruction in athletes. Med Sci Sports Exerc. 2013 Nov;45(11):2030-5. doi: 10.1249/MSS.0b013e318298b19a.
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citation: Christensen PM, Maltbaek N, Jorgensen IM, Nielsen KG. Can flow-volume loops be used to diagnose exercise induced laryngeal obstructions? A comparison study examining the accuracy and inter-rater agreement of flow volume loops as a diagnostic tool. Prim Care Respir J. 2013 Sep;22(3):306-11. doi: 10.4104/pcrj.2013.00067.