NCT Number: NCT03696602
More Relaxation by Deep Breath on Methacholine
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.
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Conditions
Age range
6 year–14 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Central Hospital, Nancy, France
Other
Registry information
Official study title
More Relaxation by Deep Breath on Methacholine- Than on Exercise-Induced Bronchoconstriction During the Routine Testing of Asthmatic Children
Acronym: SouProvocBro
Important dates
- Study start
- 2006
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Oct 4, 2018
- Registry last updated
- Oct 4, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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