Mechanisms of Exercise-induced Bronchospasm

The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that occurs during, and most often after, exercise. Manifestations of EIB can range from mild impairment of performance to severe bronchospasm and respiratory failure.

The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet been definitively characterized. We plan on comparing markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). We also will collect demographic information as well as information about asthma control and exercise habits.

Study Overview

• Status: Completed
• Conditions: Exercise-induced Bronchospasm

Detailed Description

At Visit 1, participants will complete questionnaires about demographics, asthma control (if asthmatic) and exercise habits. The participants will have baseline spirometry performed, and skin prick testing for allergies. Skin testing is important as it can influence the level of exhaled nitric oxide and hence we would like to adjust our results for the presence of allergies. Subsequently, volunteers will undergo sputum induction and then have peripheral blood drawn for microRNA analysis. MicroRNA's are single-stranded RNA molecules of about 21-23 nucleotides in length regulating gene expression. Patterns of MicroRNA expression have been linked to heart disease and cancer. Similar patterns have not been identified in exercise-induced asthma. In total, including time for questions and recovery, the time for Visit 1 will be approximately 3 hours.

At Visit 2, which will occur 24 hours to 7 days after Visit 1 in order to minimize risk of asthma exacerbation, the participants will again have baseline spirometry. Baseline exhaled nitric oxide will be performed. Eucapnic Voluntary hyperventilation testing will then be performed. They then will have a second exhaled nitric oxide quantification, will undergo sputum induction and then have peripheral blood drawn for microRNA analysis, all occurring after EVH testing. In total, including time for questions and recovery, the time for Visit 2 will be approximately 2 hours.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

EIB is one of the most common triggers of bronchospasm in asthmatics. It is identified as a trigger in 80-90% of asthmatics. It also occurs frequently (10-15%) in healthy volunteers without asthma. Inclusion of a heterogenous population of asthmatics and non-asthmatics will help provide much needed information to help compare/contrast EIB that occurs in these two groups.

Description

Inclusion Criteria:

1. Men and women
2. History of physician-diagnosed asthma
3. Age between 18 and 70 years old.
4. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. These requirements for contraception also apply to women who may have irregular or absent menstrual periods.
5. Non-smoker for 6 months or longer
6. Less than 10 pack year (number of packs per day (x) years of smoking = pack years) smoking history

Exclusion Criteria:

1. Objective evidence of severe lung impairment on pulmonary function testing performed at the beginning of the study.
2. Participation in another interventional research trial
3. Unable to provide consent
4. Pregnancy
5. Asthma exacerbation within the last 4 weeks.
6. History of severe reaction to allergy skin testing

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; 35 asthmatic participants with EIB
2; 35 without EIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH).	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
to identify important differences between non-asthmatics and asthmatics that suffer from EIB	1 week

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Jonathan P. Parsons, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 18, 2008
• First Posted (ESTIMATE): June 19, 2008

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: inflammation in asthmatic and non-asthmatic participants
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Spasm; Asthma, Exercise-Induced
• Other Study ID Numbers: 2007H0189