Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.

NCT05376436 | Unknown

• 1 other identifier: 0716-19-RMB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary end point

  15 minutes

Study Arms (1)

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

Diagnostic Test: Exercise challenge test (ECT)

Interventions

Exercise challenge test (ECT) 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.

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

Study Officials

• Lea Bentur, MD

  Rambam Medical Center Haifa, Israel.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Bentur, MD

CONTACT

+97244360; l_bentur@rambam.health.gov.il

Ronen Bar-Yoseph, MD

CONTACT

+97247774360; r_bar-yoseph@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: August 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)