Diagnostics and Quality of Life With EIA and EILO

NCT03550456 | Completed

• 1 other identifier: KGU-83/18
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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and contain 120 items (CBCL/4-18) and 119 items (YSR), respectively, in eight different categories: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, and aggressive behavior.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.

  5 years

Secondary Outcomes (4)

• Symptoms of EIA and EILO

  5 years

• Prevalence

  1 year

• Speech therapy

  5 years

• Carbon dioxide

  5 years

Study Arms (1)

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.

Other: ECC; Other: ECC with CLE; Other: Speech therapy

Interventions

ECC OTHER

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.

ECC, ECC with CLE, speech therapy

ECC with CLE OTHER

Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.

ECC, ECC with CLE, speech therapy

Speech therapy OTHER

Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.

ECC, ECC with CLE, speech therapy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (15)

• 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.

  PMID: 23634861 BACKGROUND

• 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.

  PMID: 19161635 BACKGROUND

• 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.

  PMID: 22789953 BACKGROUND

• 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.

  PMID: 19585139 BACKGROUND

• 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.

  PMID: 22326606 BACKGROUND

• 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.

  PMID: 19596563 BACKGROUND

• 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.

  PMID: 21912178 BACKGROUND

• 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.

  PMID: 22989372 BACKGROUND

• 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.

  PMID: 27492717 BACKGROUND

• 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.

  PMID: 27717246 BACKGROUND

• 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.

  PMID: 25380758 BACKGROUND

• 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.

  PMID: 23657163 BACKGROUND

• 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.

  PMID: 16481809 BACKGROUND

• 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.

  PMID: 21528411 BACKGROUND

• 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.

  PMID: 23955336 BACKGROUND

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

Eukaryotic Initiation Factor-2B; Speech Therapy

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guanine Nucleotide Exchange Factors; GTP-Binding Protein Regulators; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Eukaryotic Initiation Factors; Peptide Initiation Factors; Ribosomal Proteins; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Johannes Schulze, Assoc. Prof.

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 8, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

DE (1)