More Relaxation by Deep Breath on Methacholine (SouProvocBro)
More Relaxation by Deep Breath on Methacholine- Than on Exercise-Induced Bronchoconstriction During the Routine Testing of Asthmatic Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children were referred to the lung function department by their pediatric pulmonologist. Asthma was defined by a complaint of wheezing, cough, dyspnoea or chest tightness at rest or on exercising and a positive response to methacholine or exercise challenge.
The response to exercise was considered positive when Forced Expiratory Volume in 1 s (FEV1) decreased at least 8% from Baseline.
The response to methacholine was considered positive when FEV1 decreased at least 20% or Rrs increased at least 50% from baseline, at or below a cumulated dose of 1,200 μg.
Bronchodilator medications were discontinued at least 12 hours prior to the testing and provocation allowed when the child had been free of respiratory symptoms for at least 2 weeks and baseline FEV1 was larger than 70% pred. Exercise and methacholine groups were matched for age, height, baseline FEV1 z-score, a moderate level of airway response to challenge and DI amplitude ranging 40-60% of the predicted Forced Vital Capacity (FVC). Written informed consent was obtained from the children and their parents for the procedures. Procedures for spirometry, exhaled fraction of NO (FENO), GrsDI (Respiratory conductance response to a deep inhalation) and challenges have been described previously. Acceptable GrsDI's were analyzed at a 10-20% FEV1 decrease from baseline. Statistics were performed using Mann-Whitney, Chi square tests and multiple regression as required. Data are median and interquartile range.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other respiratory diseases than asthma
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
test with methacholine
|
|
|
test with exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grs change between before deep breath and after deep breath in exercise and metacholine groups
Time Frame: through study completion, an average of 1 hour
|
GrsDI represents Grs measured after deep breath reported to Grs before deep breath (bronchial provocation test)
|
through study completion, an average of 1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- enf4327
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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