A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma



Status:Not yet recruiting
Conditions:Asthma, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:8 - 21
Updated:5/27/2013
Start Date:April 2010
Contact:Claudia Fernandez, MD
Email:cfernandez@winthrop.org
Phone:516-663-3832

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Exercise induced bronchospasm (EIB), also known as exercise induced asthma (EIA) is a
transient obstruction to airflow triggered by exertion.

It is now a well known identity, center of discussion in recent years, particularly in the
athletes' world. It is more common in asthmatic individuals (regardless of severity of
disease), but it is also seen in otherwise healthy subjects, leading to the general
consensus that the pathophysiology is different than asthma.

The concentration of exhaled nitric oxide (FeNO) in various airway & respiratory disorders,
particularly asthma, has been deeply studied. Its use for noninvasive monitoring of asthma
control (reflecting airway eosinophilic inflammation) is being closely examined and put into
clinical practice. FeNO is significantly elevated in asthma. Elevated FeNO levels have
also been noted in patients hospitalized with a COPD exacerbation, acidosis, rhinitis,
bronchiectasis, active pulmonary sarcoidosis, active fibrosing alveolitis, and acute lung
allograft rejection. Decreased FeNO levels have been seen in patients with primary ciliary
dyskinesia, cystic fibrosis, PiZZ phenotype-related alpha-1 antitrypsin deficiency, and
pulmonary hypertension

Two studies have addressed the variations on FeNO after EIB and they had contradictory
results. Scollo et al. found no change in FeNO in either healthy or asthmatic children after
a 6-min of vigorous exertion in an exercise laboratory when they studied 24 asthmatic and 18
control children. Terada et al. reported, for 39 subjects, a decrease in FeNO in subjects
with EIB and an increase in healthy controls.

It is well accepted that the pathophysiology of exercise induced bronchospasm it is not
similar to that of asthma. Certainly the inflammation in the airway does not appear to be
eosinophilic. Understanding the disease mechanism is a key factor to adequately manage it.

This will be a prospective study measuring online exhaled nitric oxide involving children 8
to 21 years old. The study group will include any children coming for a pulmonary exercise
test in the exercise laboratory located in the Pediatric Pulmonary Division office.

The study will be conducted from the fall of 2009 until the spring of 2011. The change in
the FeNO measurement will be correlated with the change in % predicted FEV1. We will
consider significant a decrease in FEV1 post exercise of 15% and/or decrease on FEF25-75 of
20% that will persist until 15 minutes after completing exercise.

We will also record any symptoms reported by the subject during or after the test.

An exercise test is a standard of care when suspecting exercise-induced asthma. The subjects
and their parents coming for exercise test will be offered the opportunity to participate in
the study.

The subject will come for the exercise test and will perform spirometry and FeNO measurement
prior to start the test. According to our exercise laboratory protocol 1 minute of warm up
at a low speed, followed by 6 minutes of high speed (enough to increase heart rate to 90%
predicted or more) and 3 minutes of cool down at a low speed will be performed.

Then spirometry will be repeated at 3, 5, 10 and 15 minutes and FeNO measurement will be
taken at 5, 10 and 15 minutes.

We will analyze the data to find if there is any significant change in FeNO measurements
after exercise.


Inclusion Criteria:

- Subjects between the ages of 8-21 years of age coming for an exercise stress test at
the Pediatric Pulmonary office at Winthrop University Hospital with symptoms
consistent with exercise induced asthma

Exclusion Criteria:

- Do not meet the diagnosis of exercise induced asthma

- Can not perform a sub-maximal exercise test on a treadmill due to orthopedic
limitations

- Are under age 8 years old and will not be able to perform an exercise test and/or
nitric oxide test

- Have severe persistent asthma with baseline increased levels of nitric oxide

- Diagnosed with any chronic lung disease, hypertension, heart failure, pulmonary
hypertension, primary ciliary dyskinesia, bronchiectasis, alveolitis, lung transplant
rejection, pulmonary sarcoidosis, chronic cough (i.e. greater four weeks), systemic
sclerosis, hypersensitivity, cystic fibrosis, HIV, sickle cell anemia, cardiac
pulmonary bypass, liver cirrhosis, alpha-1 anti-trypsin disease and interstitial lung
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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