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NCT Number: NCT03550456

Diagnostics and Quality of Life With EIA and EILO

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.

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Key information

Conditions

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

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECC

Other

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

ECC with CLE

Other

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

Speech therapy

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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