Exercise Challenge in a Cold Chamber

N/ACompletedNCT02026492

Johann Wolfgang Goethe University Hospital79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Exercise-induced Asthma

Interventions

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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