Exercise Challenge in a Cold Chamber

Exercise-induced Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026492
• Other study ID #: KGU-208/13
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: March 16, 2015
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Exercise-induced Asthma

Intervention

Other:
• 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.
• Methacholine challenge
nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
• 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.

Locations

Country	Name	City	State
Germany	Goethe University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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;10:4. doi: 10.1186/1465-9921-10-4. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agreement of the combined exercise/cold-air challenge with the Asthma-score	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.	3 months	No
Primary	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.	3 months	No
Secondary	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.	3 months	No