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Clinical Trials/NCT05376436
NCT05376436
Unknown
Not Applicable

The Effect of Mouth Breathing on Exercise Induced Bronchoconstriction in Children.

Rambam Health Care Campus1 site in 1 country100 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma in Children
Sponsor
Rambam Health Care Campus
Enrollment
100
Locations
1
Primary Endpoint
Primary end point
Last Updated
3 years ago

Overview

Brief Summary

Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.

Aim: Asses the effect of a nose clip and allergic rhinitis in EIB. Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.

Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel. Children referred for ECT will be registered to the study and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.

Detailed Description

Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is evaluated with serial measurements of lung functions during exercise protocol. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways. Aim: Asses the effect of a nose clip and allergic rhinitis in exercise induced bronchoconstriction. Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends. Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel, during 2020-2021. Children referred for ECT will be registered to the study after signing an informed consent and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. ECT will be conducted according to the institute protocol, based on American Thoracic Society (ATS) guidelines. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Exercise challenge test as part of exercise induced asthma evaluation.
  • Age 6-18 years.

Exclusion Criteria

  • Other chronic lung disease
  • Significant background illness
  • Severe asthma exacerbation or systemic steroids - last 2 months
  • Persistent use of inhaled steroids - last 2 weeks
  • Use of short acting bronchodilators - last 24 hours.

Outcomes

Primary Outcomes

Primary end point

Time Frame: 15 minutes

Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.

Secondary Outcomes

  • Secondary end point(15 minutes)

Study Sites (1)

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