Asthma, Exercise InducedNCT00710255
Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm
An observational study of Asthma, Exercise Induced, run by University of Vermont at 1 site in United States.
Trial summary
This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma, Exercise Induced
- What is being tested?
- Hyperpnea challenge
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asthmatics with exercise induced bronchospasm
Who may be able to join
- Physician diagnosed asthma
- Age 12-75 yrs
- FEV1 > 70% predicted
- HIB response > 10 %
- No smoking last 6 mo and < 10 pack yrs
- No URI last 4 weeks
- No asthma exacerbation last 4 weks
- Able to withhold SABA > 8 hrs and LABA > 24 hrs
Who cannot join
- Other lung disease
- Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.
This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.
- Conditions
- Asthma, Exercise Induced
- Being tested
- Hyperpnea challenge
- Keywords
- Asthma, Exercise induced bronchospasm, Hyperpnea induced bronchospasm, leukotrienes, adenosine, exhaled breath condensate
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpnea challengeProcedure or surgery
5 minutes of dry air hyperpnea to induce bronchospasm
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Asthmatics with exercise induced bronchospasm Receives: Procedure: Hyperpnea challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of cystLTs and adenosine
Measured: Before and after hyperpnea challenge
Secondary outcomes (1)
Change in pH of EBC and change in pulmonary function
Measured: Before and after hyperpnea challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Exercise InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kaminsky, MD, University of Vermont
- Investigators
- David A. Kaminsky, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710255
- Sponsor's protocol ID
- CHRMS 08-023
- Other IDs
- Merck IISP 32710
- Status last verified
- Oct 2016
- First submitted
- 2 Jul 2008
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.
- ClinicalTrials.gov ID
- NCT00710255
- Acronym / sponsor ID
- CHRMS 08-023
- Conditions
- Asthma, Exercise Induced
- Keywords
- Asthma, Exercise induced bronchospasm, Hyperpnea induced bronchospasm, leukotrienes, adenosine, exhaled breath condensate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | – | Procedure: Hyperpnea challengeAsthmatics with exercise induced bronchospasm |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthmatics with exercise induced bronchospasm
Key inclusion criteria (8 listed)
- Physician diagnosed asthma
- Age 12-75 yrs
- FEV1 > 70% predicted
- HIB response > 10 %
- No smoking last 6 mo and < 10 pack yrs
Key exclusion criteria (2 listed)
- Other lung disease
- Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpnea challenge5 minutes of dry air hyperpnea to induce bronchospasm | Procedure or surgery | Asthmatics |
Primary outcome
Change in level of cystLTs and adenosine
Time frame: Before and after hyperpnea challenge
1 secondary outcome
Change in pH of EBC and change in pulmonary function
Time frame: Before and after hyperpnea challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
Related trials for Asthma, Exercise Induced
Not yet recruitingObservational study
Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease
COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis)
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Asthma in Children, Exercise Induced Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Kaminsky, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, Exercise Induced, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of cystLTs and adenosine (time frame: Before and after hyperpnea challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.