Clinical trial NCT01214551: Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
Official title: Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Induced Bronchoconstriction
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Klinikk for allergi og luftveissykdommer
First posted: 2010-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to Klinikk for allergi og luftveissykdommer

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Referred to Klinikk for allergi og luftveissykdommer
* Meet at least 3 out of 5 criteria (symptoms related to exercise):

  1. Cough during exercise or within 5 minutes after exercise
  2. Wheeze during exercise or within 5 minutes after exercise
  3. Heavy breathing, expiratory in particular, during exercise or within 5 minutes after exercise (duration 5 minutes or more)
  4. Improvement of physical fitness/breath is lacking despite of exercise intensification
  5. 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

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: up to 4 weeks
measure: Forced expiratory flow at 50 % FVC(FEF50%)
timeFrame: up to 4 weeks
measure: Fractional exhaled nitric oxide (FENO)
timeFrame: up to 4 weeks
measure: Total lung capacity (TLC)
timeFrame: up to 4 weeks
measure: Specific airway resistance (sRAW)
timeFrame: up to 4 weeks
measure: Specific airway conductance (sGAW)
timeFrame: up to 4 weeks
measure: Residual volume (RV)
timeFrame: up to 4 weeks
measure: Diffusing capacity (TLCO)
timeFrame: up to 4 weeks
measure: Maximum voluntary ventilation (MVV)
timeFrame: up to 4 weeks
measure: Breathing reserve (BR)
timeFrame: up to 4 weeks
measure: Respiratory exchange ration (RER)
timeFrame: up to 4 weeks
measure: Oxygen uptake peak (VO2 peak)
timeFrame: up to 4 weeks
measure: Heart rate peak (HR peak)
timeFrame: up to 4 weeks
measure: Ventilation peak (VE peak)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Klinikk for allergi og luftveissykdommer
state: Ullevål
Study officials:
affiliation: Norwegian University of Science and Technology
name: Liv B Augestad, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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