Exercise Induced BronchoconstrictionNCT01214551
Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
An observational study of Exercise Induced Bronchoconstriction, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Exercise Induced Bronchoconstriction
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects referred to Klinikk for allergi og luftveissykdommer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Exercise Induced Bronchoconstriction
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Measured: up to 4 weeks
Secondary outcomes (14)
Forced vital capacity (FVC)
Measured: up to 4 weeks
Forced expiratory flow at 50 % FVC(FEF50%)
Measured: up to 4 weeks
Fractional exhaled nitric oxide (FENO)
Measured: up to 4 weeks
Total lung capacity (TLC)
Measured: up to 4 weeks
Specific airway resistance (sRAW)
Measured: up to 4 weeks
Specific airway conductance (sGAW)
Measured: up to 4 weeks
Residual volume (RV)
Measured: up to 4 weeks
Diffusing capacity (TLCO)
Measured: up to 4 weeks
Maximum voluntary ventilation (MVV)
Measured: up to 4 weeks
Breathing reserve (BR)
Measured: up to 4 weeks
Respiratory exchange ration (RER)
Measured: up to 4 weeks
Oxygen uptake peak (VO2 peak)
Measured: up to 4 weeks
Heart rate peak (HR peak)
Measured: up to 4 weeks
Ventilation peak (VE peak)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced BronchoconstrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikk for allergi og luftveissykdommer
- Responsible party
- Sponsor
- Investigators
- Liv B Augestad, Professor, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214551
- Sponsor's protocol ID
- 2010/1551-4
- Status last verified
- Feb 2017
- First submitted
- 23 Sep 2010
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
- ClinicalTrials.gov ID
- NCT01214551
- Acronym / sponsor ID
- 2010/1551-4
- Conditions
- Exercise Induced Bronchoconstriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Klinikk for allergi og luftveissykdommer
- Study start
- Aug 2010 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects referred to Klinikk for allergi og luftveissykdommer
Key inclusion criteria (8 listed)
- Referred to Klinikk for allergi og luftveissykdommer
- Meet at least 3 out of 5 criteria (symptoms related to exercise):
- Patients former diagnosed with-and treated for asthma who have symptoms of EIB are included in the study.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: up to 4 weeks
14 secondary outcomes
Forced vital capacity (FVC)
Time frame: up to 4 weeks
Forced expiratory flow at 50 % FVC(FEF50%)
Time frame: up to 4 weeks
Fractional exhaled nitric oxide (FENO)
Time frame: up to 4 weeks
Total lung capacity (TLC)
Time frame: up to 4 weeks
Specific airway resistance (sRAW)
Time frame: up to 4 weeks
Specific airway conductance (sGAW)
Time frame: up to 4 weeks
Residual volume (RV)
Time frame: up to 4 weeks
Diffusing capacity (TLCO)
Time frame: up to 4 weeks
Maximum voluntary ventilation (MVV)
Time frame: up to 4 weeks
Breathing reserve (BR)
Time frame: up to 4 weeks
Respiratory exchange ration (RER)
Time frame: up to 4 weeks
Oxygen uptake peak (VO2 peak)
Time frame: up to 4 weeks
Heart rate peak (HR peak)
Time frame: up to 4 weeks
Ventilation peak (VE peak)
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publicationAngell 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liv B Augestad, Professor principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Induced Bronchoconstriction, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.