Exercise Challenge in a Cold Chamber

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Exercise-induced Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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40 patients aged 6-18 years

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.

Group Type OTHER

Exercise challenge in a cold chamber

Intervention Type OTHER

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

Methacholine challenge

Intervention Type OTHER

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

Exercise challenge in room temperature

Intervention Type OTHER

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

40 subjects aged 18-45 years

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.

Group Type OTHER

Exercise challenge in a cold chamber

Intervention Type OTHER

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

Methacholine challenge

Intervention Type OTHER

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

Exercise challenge in room temperature

Intervention Type OTHER

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

Interventions

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Exercise challenge in a cold chamber

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

Intervention Type OTHER

Methacholine challenge

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

Intervention Type OTHER

Exercise challenge in room temperature

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No