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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

September 23, 2010
November 15, 2011
August 2010
March 2011   (final data collection date for primary outcome measure)
Forced expiratory volume in one second (FEV1) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
Forced expiratory volume in one second (FEV1) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01214551 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Forced vital capacity (FVC) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Forced expiratory flow at 50 % FVC(FEF50%) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Fractional exhaled nitric oxide (FENO) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Total lung capacity (TLC) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Specific airway resistance (sRAW) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Specific airway conductance (sGAW) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Residual volume [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Diffusing capacity (TLCO) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Maximum voluntary ventilation [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Breathing reserve (BR) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Respiratory exchange ration (RER) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Oxygen uptake peak (VO2 peak) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Heart rate peak [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Questionnaire [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
  • Ventilation peak (VE peak) [ Time Frame: 01.09.10-01.07.2011 ] [ Designated as safety issue: No ]
Not Provided
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Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test
Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects referred to Klinikk for allergi og luftveissykdommer

Exercise Induced Bronchoconstriction
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01214551
2010/1551-4
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Klinikk for allergi og luftveissykdommer
Principal Investigator: Liv B Augestad, Professor Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP