Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376436
• Other study ID #: 0716-19-RMB
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: Rambam Health Care Campus
• Contact: Lea Bentur, MD
• Phone: +97244360
• Email: l_bentur[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma in Children
• Mouth Breathing

Intervention

Diagnostic Test:
• Exercise challenge test (ECT)
Baseline demographic, clinical and rest lung functions were recorded. ECT was performed on treadmill according to fixed protocol. Clinical data during ECT was recorded. (visit 1- performed with nose clip, visit 2- performed without nose clip). Lung function were measured and recorded at fixed time after ECT and after bronchodilator administration.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary end point	Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.	15 minutes
Secondary	Secondary end point	Forced expiratory volume in one second - (FEV1) improvement after bronchodilators during exercise challenge test with and without Nose clip	15 minutes