Diagnostics and Quality of Life With EIA and EILO

July 28, 2020 updated by: Johannes Schulze MD, Johann Wolfgang Goethe University Hospital

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

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Goethe University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of EIA and EILO
Time Frame: 5 years
Comparison of symptom score ACT and DI between EIA and EILO.
5 years
Prevalence
Time Frame: 1 year
Patients suffering from exercise induced dyspnea are evaluated of prevalence of EIA-, EILO and combinations of EIA+EILO.
1 year
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Johannes Schulze, Assoc. Prof., Johann Wolfgang Goethe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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