Exercise Induced AsthmaNCT03550456
Diagnostics and Quality of Life With EIA and EILO
An observational study of Exercise Induced Asthma and Exercise Induced Pharyngeal Collapse, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Exercise Induced Asthma, Exercise Induced Pharyngeal Collapse
- What is being tested?
- ECC, ECC with CLE and Speech therapy
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from our outpatient clinic aged 8-18 years with exercise induced dyspnea and at least two training session per week.
Who may be able to join
- 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%
Who cannot join
- 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
Show all 10Show fewer
- acute severe infection (pneumonia) within the last 4 weeks
- intake of leukotriene-antagonists 48h before examination
- other chronic diseases or infections (HIV, Tbc)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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.
Read the 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.
- Being tested
- ECC, ECC with CLE, Speech therapy
- Keywords
- Exercise Induced Asthma (EIA), Exercise Induced Laryngeal Obstruction (EILO), Quality of life, Exercise challenge in cold chamber (ECC), Continous laryngoscopy while exercising (CLE)
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCOther
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
ECC with CLEOther
Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
Speech therapyOther
Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ECC; Other: ECC with CLE; Other: Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Symptoms of EIA and EILO
Comparison of symptom score ACT and DI between EIA and EILO.
Measured: 5 years
Prevalence
Patients suffering from exercise induced dyspnea are evaluated of prevalence of EIA-, EILO and combinations of EIA+EILO.
Measured: 1 year
Speech therapy
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.
Measured: 5 years
Carbon dioxide
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Johannes Schulze, Assoc. Prof., Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550456
- Sponsor's protocol ID
- KGU-83/18
- Status last verified
- Jul 2020
- First submitted
- 23 May 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23634861Anderson 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.
PubMed 19161635Driessen 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.
PubMed 22789953Maat 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.
PubMed 19585139Schulze 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.
PubMed 22326606Schulze 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.
PubMed 19596563Schulze 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.
PubMed 21912178Schulze 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.
PubMed 22989372Roksund 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.
PubMed 27492717Buchvald 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.
PubMed 27717246Johansson 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.
PubMed 25380758Nielsen 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.
PubMed 23657163Heimdal 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.
PubMed 16481809Christensen 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.
PubMed 21528411Christensen 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.
PubMed 23955336
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics of the Quality of Life With Exercise Induced Asthma (EIA) and Exercise Induced Laryngeal Obstruction (EILO)
- ClinicalTrials.gov ID
- NCT03550456
- Acronym / sponsor ID
- KGU-83/18
- Keywords
- Exercise Induced Asthma (EIA), Exercise Induced Laryngeal Obstruction (EILO), Quality of life, Exercise challenge in cold chamber (ECC), Continous laryngoscopy while exercising (CLE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECC, ECC with CLE, speech therapy | – | Other: ECC, Other: ECC with CLE, Other: Speech therapyAfter 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from our outpatient clinic aged 8-18 years with exercise induced dyspnea and at least two training session per week.
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECCExercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. | Other | ECC, ECC with CLE, speech therapy |
| ECC with CLEContinuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise. | Other | ECC, ECC with CLE, speech therapy |
| Speech therapyPatients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions. | Other | ECC, ECC with CLE, speech therapy |
Primary outcome
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.
4 secondary outcomes
Symptoms of EIA and EILO
Time frame: 5 years
Prevalence
Time frame: 1 year
Speech therapy
Time frame: 5 years
Carbon dioxide
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 23634861Parsons 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.
- Background: PubMed 19161635Anderson 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.
- Background: PubMed 22789953Driessen 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.
- Background: PubMed 19585139Maat 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.
- Background: PubMed 22326606Schulze 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.
- Background: PubMed 19596563Schulze 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.
- Background: PubMed 21912178Schulze 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.
- Background: PubMed 22989372Schulze 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.
- Background: PubMed 27492717Roksund 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.
- Background: PubMed 27717246Buchvald 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.
- Background: PubMed 25380758Johansson 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.
- Background: PubMed 23657163Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Schulze, Assoc. Prof. principal investigator
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Induced Asthma and Exercise Induced Pharyngeal Collapse, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in subjects with exercise induced asthma and exercise induced laryngeal obstruction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550456, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.