An interventional study of Exercise challenge in a cold chamber and Methacholine challenge in Exercise-induced Asthma, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 6 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 79 is above the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.
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From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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FEV1
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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All 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.
Other: Exercise challenge in a cold chamber · Other: Methacholine challenge · Other: Exercise challenge in room temperature
All 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.
Other: Exercise challenge in a cold chamber · Other: Methacholine challenge · Other: Exercise challenge in room temperature
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.
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.
Time frame: 3 months
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.
Time frame: 3 months
Agreement of the combined exercise/cold-air challenge with the Asthma-score
All children who participate will fill the asthma control test (ACT) and all adult subjects will fill the asthma control questionnaire (ACQ). The asthma-score will be compared with the severity of the exercise induced asthma measured by the maximal fall in FEV1.
Time frame: 3 months
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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