NCT01214551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

September 23, 2010

Last Update Submit

February 7, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume in one second (FEV1)

    up to 4 weeks

Secondary Outcomes (14)

  • Forced vital capacity (FVC)

    up to 4 weeks

  • Forced expiratory flow at 50 % FVC(FEF50%)

    up to 4 weeks

  • Fractional exhaled nitric oxide (FENO)

    up to 4 weeks

  • Total lung capacity (TLC)

    up to 4 weeks

  • Specific airway resistance (sRAW)

    up to 4 weeks

  • +9 more secondary outcomes

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to Klinikk for allergi og luftveissykdommer

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikk for allergi og luftveissykdommer

Oslo, Ullevål, 0855, Norway

Location

Related 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_2014043017202072.pdf

    RESULT

Study Officials

  • Liv B Augestad, Professor

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

October 5, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations