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

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ClinicalTrials.gov Identifier: NCT01097954
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Melodi Pirzada MD, Winthrop University Hospital

March 31, 2010
April 2, 2010
June 14, 2013
April 2010
June 2013   (Final data collection date for primary outcome measure)
Variations in the fraction of exhaled nitric oxide in subjects with exercise induced asthma [ Time Frame: 1 year ]
The exhaled Nitric Oxide (FeNO) will be measured before the exercise test and at 5, 10 and 15 min after completion of the exercise to detect variations in the value
Same as current
Complete list of historical versions of study NCT01097954 on ClinicalTrials.gov Archive Site
  • Correlation between level of FeNO and reduction in FEV1 [ Time Frame: 1 year ]
    Variations in the FeNO will be compared to FEV1 changes to see if they correlate
  • Correlation between level of FeNO and severity of symptoms [ Time Frame: 1 year ]
    Variations in FeNO will be correlated with symptoms reported
Same as current
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A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma
A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Subject with symptoms consistent with exercise induced asthma
Exercise Induced Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
100
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01097954
146548
Yes
Not Provided
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Melodi Pirzada MD, Winthrop University Hospital
Melodi Pirzada MD
Not Provided
Principal Investigator: Melodi Pirzada, MD Winthrop University Hospital
Winthrop University Hospital
June 2013