Study Results
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Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2018-11-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
ECC
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
ECC with CLE
Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
Speech therapy
Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
Interventions
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ECC
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
ECC with CLE
Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
Speech therapy
Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
18 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Johannes Schulze MD
Prof.
Principal Investigators
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Johannes Schulze, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital
Locations
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Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Countries
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References
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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.
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.
Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.
Maat RC, Roksund OD, Halvorsen T, Skadberg BT, Olofsson J, Ellingsen TA, Aarstad HJ, Heimdal JH. Audiovisual assessment of exercise-induced laryngeal obstruction: reliability and validity of observations. Eur Arch Otorhinolaryngol. 2009 Dec;266(12):1929-36. doi: 10.1007/s00405-009-1030-8. Epub 2009 Jul 8.
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.
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.
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.
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.
Roksund OD, Heimdal JH, Clemm H, Vollsaeter M, Halvorsen T. Exercise inducible laryngeal obstruction: diagnostics and management. Paediatr Respir Rev. 2017 Jan;21:86-94. doi: 10.1016/j.prrv.2016.07.003. Epub 2016 Jul 18.
Buchvald F, Phillipsen LD, Hjuler T, Nielsen KG. Exercise-induced inspiratory symptoms in school children. Pediatr Pulmonol. 2016 Nov;51(11):1200-1205. doi: 10.1002/ppul.23530. Epub 2016 Sep 22.
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.
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.
Heimdal JH, Roksund OD, Halvorsen T, Skadberg BT, Olofsson J. Continuous laryngoscopy exercise test: a method for visualizing laryngeal dysfunction during exercise. Laryngoscope. 2006 Jan;116(1):52-7. doi: 10.1097/01.mlg.0000184528.16229.ba.
Christensen PM, Thomsen SF, Rasmussen N, Backer V. Exercise-induced laryngeal obstructions: prevalence and symptoms in the general public. Eur Arch Otorhinolaryngol. 2011 Sep;268(9):1313-9. doi: 10.1007/s00405-011-1612-0. Epub 2011 Apr 29.
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.
Other Identifiers
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KGU-83/18
Identifier Type: -
Identifier Source: org_study_id
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