Mechanisms of Exercise-induced Bronchospasm

NCT00701025 | Completed DMC

• 1 other identifier: 2007H0189
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exercise-induced Bronchospasm

Keywords

inflammation in asthmatic and non-asthmatic participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to identify important differences between non-asthmatics and asthmatics that suffer from EIB

  1 week

Study Arms (2)

1

35 asthmatic participants with EIB

2

35 without EIB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men and women
• History of physician-diagnosed asthma
• Age between 18 and 70 years old.
• 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.
• Non-smoker for 6 months or longer
• Less than 10 pack year (number of packs per day (x) years of smoking = pack years) smoking history

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, sputum, urine for pregnancy testing

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jonathan P. Parsons, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Internal Medicine

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)