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Completed

NCT Number: NCT02026492

Exercise Challenge in a Cold Chamber

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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Key information

Conditions

Exercise-induced Asthma Asthma Asthma, Exercise-Induced Bronchial Diseases Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise challenge in a cold chamber

Other

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

Methacholine challenge

Other

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

Exercise challenge in room temperature

Other

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

Primary outcomes

  1. Agreement of metacholine challenge and the combined exercise/cold-air challenge

    Time frame: 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 outcomes

  1. Repeatability of the combined exercise/cold-air challenge

    Time frame: 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.

Other outcomes

  1. Agreement of the combined exercise/cold-air challenge with the Asthma-score

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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