Back to resultsExercise Challenge in a Cold Chamber
Primary Purpose
Exercise-induced Asthma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise challenge in a cold chamber
Methacholine challenge
Exercise challenge in room temperature
Sponsored by
About this trial
This is an interventional diagnostic trial for Exercise-induced Asthma focused on measuring exercise-induced bronchoconstriction, exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, combined exercise- and cold-air challenge, methacholine challenge
Eligibility Criteria
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
Sites / Locations
- Goethe University Hospital Frankfurt
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
40 patients aged 6-18 years
40 subjects aged 18-45 years
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02026492
First Posted
December 19, 2013
Last Updated
March 16, 2015
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02026492
Brief Title
Exercise Challenge in a Cold Chamber
Official Title
Exercise-induced Bronchoconstriction in a Cold Chamber Compared to Methacholine Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Asthma
Keywords
exercise-induced bronchoconstriction, exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, combined exercise- and cold-air challenge, methacholine challenge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 patients aged 6-18 years
Arm Type
Other
Arm 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.
Arm Title
40 subjects aged 18-45 years
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Exercise challenge in a cold chamber
Intervention Description
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Intervention Type
Other
Intervention Name(s)
Methacholine challenge
Intervention Description
nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
Intervention Type
Other
Intervention Name(s)
Exercise challenge in room temperature
Intervention Description
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.
Primary Outcome Measure Information:
Title
Agreement of metacholine challenge and the combined exercise/cold-air challenge
Description
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 Outcome Measure Information:
Title
Repeatability of the combined exercise/cold-air challenge
Description
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
Other Pre-specified Outcome Measures:
Title
Agreement of the combined exercise/cold-air challenge with the Asthma-score
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Schulze, MD
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Goethe University Hospital Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19596563
Citation
Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
Results Reference
background
PubMed Identifier
20668015
Citation
Anderson SD. Indirect challenge tests: Airway hyperresponsiveness in asthma: its measurement and clinical significance. Chest. 2010 Aug;138(2 Suppl):25S-30S. doi: 10.1378/chest.10-0116.
Results Reference
background
PubMed Identifier
23634861
Citation
Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
Results Reference
background
PubMed Identifier
19161635
Citation
Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
Results Reference
background
PubMed Identifier
22789953
Citation
Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.
Results Reference
background
PubMed Identifier
31097027
Citation
Dressler M, Friedrich T, Lasowski N, Herrmann E, Zielen S, Schulze J. Predictors and reproducibility of exercise-induced bronchoconstriction in cold air. BMC Pulm Med. 2019 May 16;19(1):94. doi: 10.1186/s12890-019-0845-3.
Results Reference
derived
Learn more about this trial
Exercise Challenge in a Cold Chamber
We'll reach out to this number within 24 hrs