ClinicalTrials.gg
CompletedNCT00701025Updated Nov 1, 2021

Mechanisms of Exercise-induced Bronchospasm

An observational study in Exercise-induced Bronchospasm, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exercise-induced Bronchospasm

Keywords

  • inflammation in asthmatic and non-asthmatic participants
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    35 asthmatic participants with EIB

  • 2

    35 without EIB

06

What researchers measure

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).

    Time frame: 1 week

Secondary outcomes

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

    Time frame: 1 week

07

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00701025
Responsible party
Jonathan Parsons (Professor of Clinical Internal Medicine, Ohio State University) — Principal investigator
First posted
Jun 19, 2008
Start date
Apr 2008
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Nov 1, 2021

Study contacts

Jonathan P. Parsons, M.D.
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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