Exercise Challenge in a Cold Chamber

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Exercise-induced Asthma

Treatments: Other: Exercise challenge in room temperature; Other: Methacholine challenge; Other: Exercise challenge in a cold chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT02026492

KGU-208/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 6 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

40 patients aged 6-18 years

Other group

Description:

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.

Treatment:

Other: Methacholine challenge

Other: Exercise challenge in room temperature

Other: Exercise challenge in a cold chamber

40 subjects aged 18-45 years

Other group

Description:

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.

Treatment:

Other: Methacholine challenge

Other: Exercise challenge in room temperature

Other: Exercise challenge in a cold chamber