Clinical trial NCT02026492: Exercise Challenge in a Cold Chamber
Official title: Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Asthma
Keywords: exercise-induced bronchoconstriction
exercise-induced asthma
cold chamber
exercise challenge
cold air challenge
combined exercise- and cold-air challenge
methacholine challenge
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 79
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Agreement of metacholine challenge and the combined exercise/cold-air challenge
timeFrame: 3 months
Secondary outcomes:
measure: Repeatability of the combined exercise/cold-air challenge
timeFrame: 3 months
Other outcomes:
measure: Agreement of the combined exercise/cold-air challenge with the Asthma-score
timeFrame: 3 months
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Johannes Schulze, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.