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Exercise-induced AsthmaNCT02026492

Exercise Challenge in a Cold Chamber

A study testing Exercise challenge in a cold chamber, Methacholine challenge and Exercise challenge in room temperature in people with Exercise-induced Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured. Read more about this study

Who is it for?
Ages 6 to 45 years
Conditions the study is for
Exercise-induced Asthma
What is being tested?
Exercise challenge in a cold chamber, Methacholine challenge and Exercise challenge in room temperature
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteGermany
Study dates
Jun 2013to Jul 2014
Phase
Interventional
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 6 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Informed consent
  • Patients: Age >6 and <18 years
  • Subjects: Age >/=18 and <45 years
  • sportive, 1-2x exercise per week
  • bronchial hyperresponsiveness in the medical history

Who cannot join

  • lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
  • chronic diseases or infections (e.g. HIV, Tbc)
  • pregnancy
  • systemic corticosteroid-treatment
  • inhalative corticosteroid therapy or leukotriene antagonists <14d
  • alcohol, substance or drug abuse
  • smokers
  • inability to capture extend and consequences of the study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Goethe University Hospital Frankfurt

    Frankfurt am Main, Hesse, 60590

Other trials in Germany

About this study

Official title: Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge

The purpose of this study is to compare the exercise-challenge in a cold chamber at 2-4°C to the gold standard the metacholine challenge in subjects showing symptoms of exercise-induced bronchoconstriction. The sensitivity and repeatability of the exercise test will be measured.

Read the detailed description

Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest. To provoke asthma symptoms a provocation test is necessary, e.g., by bronchial methacholine testing or by a standardised exercise test on a treadmill. The correlation between methacholine and exercise test is fair, possibly because both methods measure different kinds of bronchial hyperresponsiveness. Moreover, the sensitivity and the repeatability of the exercise test is fair.

The value of the methacholine test to predict a positive exercise test will be measured. We hypothesize that the exercise test in a cold chamber, a combination of two provocation methods cold air and exercise, is more sensitive to detect EIB and that the test has a better repeatability.

Being tested
Exercise challenge in a cold chamber, Methacholine challenge, Exercise challenge in room temperature
Keywords
exercise-induced bronchoconstriction, exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, combined exercise- and cold-air challenge, methacholine challenge
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.

  • Exercise challenge in a cold chamberOther

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

  • Methacholine challengeOther

    nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

  • Exercise challenge in room temperatureOther

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

Study groups in NCT02026492
Study groupRoleWhat they receive
40 patients aged 6-18 yearsOtherAll 40 patients with a diagnosis of asthma are recruited from the outpatients clinic of the department of Pediatric Pneumology and Allergology of the University Hospital Frankfurt. Patients undergo a methacholine challenge and two exercise challenges in a cold chamber and one exercise challenge in room temperature.
Receives: Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Other: Exercise challenge in room temperature
40 subjects aged 18-45 yearsOtherAll subjects show bronchial hyperresponsiveness e.g. dyspnea when exercising in cold environment, in their medical history. Subjects undergo a methacholine challenge and exercise challenge in a cold chamber and one exercise challenge in room temperature.
Receives: Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Other: Exercise challenge in room temperature

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement of metacholine challenge and the combined exercise/cold-air challenge

    Lung function will be measured prior and after methacholine- and exercise/cold-air challenges. The maximal fall in forced expiratory volume in one second (FEV1, percent predicted) after methacholine and cold air challenge will be compared by statistical correlation. For both methods the sensitivity and the specificity to predict an exercise induced asthma will be calculated by a receiver operating characteristic (ROC analysis).

    All subjects receive Salbutamol to relief them from bronchial constriction at the end of the test.

    Measured: 3 months

Secondary outcomes (1)

  1. Repeatability of the combined exercise/cold-air challenge

    The combined exercise/cold-air challenge will be performed twice within one week. Post challenge the FEV1 will be measured after 5, 10, 20, and 30 minutes. The maximal fall in FEV1 (percent predicted) and the area under the curve (AUC) will be compared. The agreement and the repeatability of the maximal fall in FEV1 and of the AUC will be measured by correlation and by the method of Bland and Altman.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026492
Sponsor's protocol ID
KGU-208/13
Status last verified
Mar 2015
First submitted
19 Dec 2013
Last updated
17 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19596563

  • Anderson SD. Indirect challenge tests: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):25S-30S. doi: 10.1378/chest.10-0116.

    PubMed 20668015

  • 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 23634861

  • 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.

    PubMed 19161635

  • 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.

    PubMed 22789953

  • Dressler M, Friedrich T, Lasowski N, Herrmann E, Zielen S, Schulze J. Predictors and reproducibility of exercise-induced bronchoconstriction in cold air. BMC Pulm Med. 2019 May 16;19(1):94. doi: 10.1186/s12890-019-0845-3.

    PubMed 31097027

Questions about this trial

What is this clinical trial studying?

A study testing Exercise challenge in a cold chamber, Methacholine challenge and Exercise challenge in room temperature in people with Exercise-induced Asthma, 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 8 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 17 Mar 2015. 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?

Agreement of metacholine challenge and the combined exercise/cold-air challenge (time frame: 3 months). 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 NCT02026492, which also lists 6 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 17 Mar 2015.

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