- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214551
Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
February 7, 2017 updated by: Norwegian University of Science and Technology
The purpose of this study is to increase the knowledge of the possible diagnostic effect of exercise induced bronchoconstriction performing a repeated exercise challenge test.
Study Overview
Status
Completed
Conditions
Detailed Description
Prior studies have shown that the intensity influences the sensitivity of exercise challenge tests (ECT) and that a heart rate-based protocol does not ensure sufficient exercise intensity to induce bronchoconstriction.
It is not common clinical practice to perform a pre ECT to establish maximal heart rate or maximal oxygen uptake.
The heart rate formula recommended by ATS (HRmax= 220-age) is usually applied to determine recommended intensity of the ECT.
Conducting a second ECT, based on the knowledge of the first test, introduce the possibility to adjust the intensity on an individual basis.
In addition, based on clinical experience, patients may seem reluctant to perform maximal the first time they undergo an ECT on a treadmill.
The hypothesis is that patients are less reluctant to perform maximal the second time they undergo the test when they are more accustomed to the procedure and the treadmill by itself.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ullevål
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Oslo, Ullevål, Norway, 0855
- Klinikk for allergi og luftveissykdommer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 45 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects referred to Klinikk for allergi og luftveissykdommer
Description
Inclusion Criteria:
- Referred to Klinikk for allergi og luftveissykdommer
Meet at least 3 out of 5 criteria (symptoms related to exercise):
- Cough during exercise or within 5 minutes after exercise
- Wheeze during exercise or within 5 minutes after exercise
- Heavy breathing, expiratory in particular, during exercise or within 5 minutes after exercise (duration 5 minutes or more)
- Improvement of physical fitness/breath is lacking despite of exercise intensification
- Chest tightness during or after exercise
- Patients former diagnosed with-and treated for asthma who have symptoms of EIB are included in the study.
Exclusion Criteria:
- Ongoing respiratory infection or recent respiratory infection, judged by the responsible doctor to be of importance of the result
- The inability to perform an Exercise challenge test with maximum effort
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume in one second (FEV1)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced vital capacity (FVC)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Forced expiratory flow at 50 % FVC(FEF50%)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Fractional exhaled nitric oxide (FENO)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Total lung capacity (TLC)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Specific airway resistance (sRAW)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Specific airway conductance (sGAW)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Residual volume (RV)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Diffusing capacity (TLCO)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Maximum voluntary ventilation (MVV)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Breathing reserve (BR)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Respiratory exchange ration (RER)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Oxygen uptake peak (VO2 peak)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Heart rate peak (HR peak)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Ventilation peak (VE peak)
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Liv B Augestad, Professor, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Angell MR, Augestad LB, Haugen TS, Frostad A, Grønnerød TA, Stensrud T. Exercise-induced bronchoconstriction diagnostics: Impact of a repeated exercise challenge test. Open Journal of Respiratory Diseases 4:55-63, 2014 http://file.scirp.org/pdf/OJRD_2014043017202072.pdf
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2010
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
September 23, 2010
First Submitted That Met QC Criteria
October 3, 2010
First Posted (ESTIMATE)
October 5, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2010/1551-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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