NCT03696602

Brief Summary

Deep inhalation (DI) dilates normal airway precontracted with methacholine. The fact that this effect is diminished or absent in asthma could be explained by the presence of bronchial inflammation. The hypothesis tested was that DI induces more relaxation in methacholine induced bronchoconstriction-solely determined by the smooth muscle contraction-than in exercise induced bronchoconstriction, which is contributed to by both smooth muscle contraction and airway wall inflammation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
Last Updated

October 4, 2018

Status Verified

September 1, 2018

Enrollment Period

10 years

First QC Date

September 21, 2018

Last Update Submit

September 28, 2018

Conditions

Keywords

airway smooth muscle, asthma, bronchial test, lung function

Outcome Measures

Primary Outcomes (1)

  • Grs change between before deep breath and after deep breath in exercise and metacholine groups

    GrsDI represents Grs measured after deep breath reported to Grs before deep breath (bronchial provocation test)

    through study completion, an average of 1 hour

Study Arms (2)

test with methacholine

Diagnostic Test: bronchial provocation test

test with exercise

Diagnostic Test: bronchial provocation test

Interventions

test with exercisetest with methacholine

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Seventy-three asthmatic children (48 boys) were selected, 37 underwent exercise challenge and 36 methacholine.

You may qualify if:

  • Children referred to the lung function department by their pediatric pulmonologist.
  • Asthma defined by a complaint of wheezing, cough and dyspnoea.
  • Positive response to methacholine or exercise challenge.
  • Bronchodilator medications discontinued at least 12 h prior to the testing
  • Provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 larger than 70% pred.

You may not qualify if:

  • \- Other respiratory diseases than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Provocation Tests

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 4, 2018

Study Start

July 1, 2006

Primary Completion

June 30, 2016

Study Completion

September 30, 2016

Last Updated

October 4, 2018

Record last verified: 2018-09