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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melodi Pirzada MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01097954
First received: March 31, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition
Exercise Induced Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Variations in the fraction of exhaled nitric oxide in subjects with exercise induced asthma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Correlation between level of FeNO and reduction in FEV1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Variations in FeNO will be correlated with symptoms reported


Enrollment: 22
Study Start Date: April 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subject with symptoms consistent with exercise induced asthma

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097954

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Melodi Pirzada MD
Investigators
Principal Investigator: Melodi Pirzada, MD Winthrop University Hospital
  More Information

Publications:

Responsible Party: Melodi Pirzada MD, Chief, Division of Pediatric Pulmonary Medicine, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01097954     History of Changes
Other Study ID Numbers: 146548
Study First Received: March 31, 2010
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Exercise induced asthma
Exercise induced bronchospasm
exhaled Nitric Oxide

Additional relevant MeSH terms:
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014