Clinical trial NCT05376436: Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.
Official title: The Effect of Mouth Breathing on Exercise Induced Bronchoconstriction in Children.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma in Children
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescences (6-18 years old) referred to perform exercise challenge test as a part of exercise induced asthma evaluation.

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.

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.

Primary outcomes:
measure: Primary end point
timeFrame: 15 minutes
Secondary outcomes:
measure: Secondary end point
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Medical Center Haifa, Israel.
name: Lea Bentur, MD
role: PRINCIPAL_INVESTIGATOR
References: