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Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

This study has been completed.
Sponsor:
Collaborator:
Klinikk for allergi og luftveissykdommer
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01214551
First received: September 23, 2010
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Exercise Induced Bronchoconstriction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forced vital capacity (FVC) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Forced expiratory flow at 50 % FVC(FEF50%) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Fractional exhaled nitric oxide (FENO) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Total lung capacity (TLC) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Specific airway resistance (sRAW) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Specific airway conductance (sGAW) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Residual volume (RV) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Diffusing capacity (TLCO) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Maximum voluntary ventilation (MVV) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Breathing reserve (BR) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Respiratory exchange ration (RER) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Oxygen uptake peak (VO2 peak) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Heart rate peak (HR peak) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Ventilation peak (VE peak) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects referred to Klinikk for allergi og luftveissykdommer

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214551

Locations
Norway
Klinikk for allergi og luftveissykdommer
Oslo, Ullevål, Norway, 0855
Sponsors and Collaborators
Norwegian University of Science and Technology
Klinikk for allergi og luftveissykdommer
Investigators
Principal Investigator: Liv B Augestad, Professor Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01214551     History of Changes
Other Study ID Numbers: 2010/1551-4
Study First Received: September 23, 2010
Last Updated: November 15, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on May 22, 2013