Exercise Challenge in a Cold Chamber

Not Applicable

Completed

• Conditions: Exercise-induced Asthma
• Interventions: Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Other: Exercise challenge in room temperature

• Registration Number: NCT02026492
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-01
• Study First Posted: 2014-01-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
40 patients aged 6-18 years	Exercise challenge in room temperature	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.
40 patients aged 6-18 years	Exercise challenge in a cold chamber	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.
40 subjects aged 18-45 years	Exercise challenge in a cold chamber	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.
40 subjects aged 18-45 years	Methacholine challenge	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.
40 patients aged 6-18 years	Methacholine challenge	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.
40 subjects aged 18-45 years	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.

Primary Outcome Measures

Name	Time	Method
Agreement of metacholine challenge and the combined exercise/cold-air challenge	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Repeatability of the combined exercise/cold-air challenge	3 months	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.

Trial Locations

Locations (1)

Goethe University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany