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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
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment
Exercise Induced Asthma Exercise Induced Pharyngeal Collapse Other: ECC Other: ECC with CLE Other: Speech therapy

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Symptoms of EIA and EILO [ Time Frame: 5 years ]
    Comparison of symptom score ACT and DI between EIA and EILO.

  2. Prevalence [ Time Frame: 1 year ]
    Patients suffering from exercise induced dyspnea are evaluated of prevalence of EIA-, EILO and combinations of EIA+EILO.

  3. 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.

  4. 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.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Johannes Schulze, Assoc. Prof. +49-69-6301 5732 johannes.schulze@kgu.de
Contact: Melanie Dreßler, MD +49-69-6301 5732 melanie.dressler@kgu.de

Locations
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Germany
Goethe University Hospital Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Johannes Schulze, PD    +49 69 6301 5732    johannes.schulze@kgu.de   
Contact: Melanie Dressler, MD    +49 69 6301 5732    melanie.dressler@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Johannes Schulze, Assoc. Prof. Johann Wolfgang Goethe University Hospital

Publications:

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Responsible Party: Johannes Schulze MD, PD Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03550456     History of Changes
Other Study ID Numbers: KGU-83/18
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johannes Schulze MD, Johann Wolfgang Goethe University Hospital:
Exercise Induced Asthma (EIA)
Exercise Induced Laryngeal Obstruction (EILO)
Quality of life
Exercise challenge in cold chamber (ECC)
Continous laryngoscopy while exercising (CLE)

Additional relevant MeSH terms:
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Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases