Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.

NCT ID: NCT05376436

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2024-06-30

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.

Conditions

Asthma in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exercise challenge test (ECT) with and without nose clip (NC).

All participants after receiving informed consent were invited for 2 visits. Visit 1 - ECT performed with NC. Visit 2 - ECT performed without NC. Demographic and clinical data and measurements of vital signs, exercise data and lung functions were recorded.

ECT completed on treadmill.

Questionnaires:

Total Nasal Symptom Score (TNSS 0-6). Asthma Control Test (ACT 5-25) . Positive ECT = drop in FEV1 >12% from baseline

Exercise challenge test (ECT)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lea Bentur, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center Haifa, Israel.

Locations

Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Lea Bentur, MD

Role: CONTACT

l_bentur@rambam.health.gov.il

+97244360

Ronen Bar-Yoseph, MD

Role: CONTACT

r_bar-yoseph@rambam.health.gov.il

+97247774360

Facility Contacts

Ronen Bar-Yoseph, MD

Role: primary

r_bar-yoseph@rambam.health.gov.il

+97247774360

Other Identifiers

0716-19-RMB

Identifier Type: -

Identifier Source: org_study_id