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

Exercise Induced Bronchoconstriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214551
• Other study ID #: 2010/1551-4
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: February 7, 2017
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Induced Bronchoconstriction

Locations

Country	Name	City	State
Norway	Klinikk for allergi og luftveissykdommer	Oslo	Ullevål

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Klinikk for allergi og luftveissykdommer

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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_20140

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)		up to 4 weeks
Secondary	Forced vital capacity (FVC)		up to 4 weeks
Secondary	Forced expiratory flow at 50 % FVC(FEF50%)		up to 4 weeks
Secondary	Fractional exhaled nitric oxide (FENO)		up to 4 weeks
Secondary	Total lung capacity (TLC)		up to 4 weeks
Secondary	Specific airway resistance (sRAW)		up to 4 weeks
Secondary	Specific airway conductance (sGAW)		up to 4 weeks
Secondary	Residual volume (RV)		up to 4 weeks
Secondary	Diffusing capacity (TLCO)		up to 4 weeks
Secondary	Maximum voluntary ventilation (MVV)		up to 4 weeks
Secondary	Breathing reserve (BR)		up to 4 weeks
Secondary	Respiratory exchange ration (RER)		up to 4 weeks
Secondary	Oxygen uptake peak (VO2 peak)		up to 4 weeks
Secondary	Heart rate peak (HR peak)		up to 4 weeks
Secondary	Ventilation peak (VE peak)		up to 4 weeks