Exercise Induced AsthmaNCT01097954
A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma
An observational study of Exercise Induced Asthma, run by Winthrop University Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Exercise Induced Asthma
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2013
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subject with symptoms consistent with exercise induced asthma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
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.
Read more
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.
- Conditions
- Exercise Induced Asthma
- Keywords
- Exercise induced asthma, Exercise induced bronchospasm, exhaled Nitric Oxide
- Medical subject headings
- Asthma, Exercise-Induced
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in the fraction of exhaled nitric oxide in subjects with exercise induced asthma
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
Measured: 1 year
Secondary outcomes (2)
Correlation between level of FeNO and reduction in FEV1
Variations in the FeNO will be compared to FEV1 changes to see if they correlate
Measured: 1 year
Correlation between level of FeNO and severity of symptoms
Variations in FeNO will be correlated with symptoms reported
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melodi Pirzada, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097954
- Sponsor's protocol ID
- 146548
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2010
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson SD, Kippelen P. Airway injury as a mechanism for exercise-induced bronchoconstriction in elite athletes. J Allergy Clin Immunol. 2008 Aug;122(2):225-35; quiz 236-7. doi: 10.1016/j.jaci.2008.05.001. Epub 2008 Jun 12.
PubMed 18554705Sue-Chu M, Larsson L, Bjermer L. Prevalence of asthma in young cross-country skiers in central Scandinavia: differences between Norway and Sweden. Respir Med. 1996 Feb;90(2):99-105. doi: 10.1016/s0954-6111(96)90206-1.
PubMed 8730329Baraldi E, de Jongste JC; European Respiratory Society/American Thoracic Society (ERS/ATS) Task Force. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37. doi: 10.1183/09031936.02.00293102.
PubMed 12166573Ricciardolo FL, Sterk PJ, Gaston B, Folkerts G. Nitric oxide in health and disease of the respiratory system. Physiol Rev. 2004 Jul;84(3):731-65. doi: 10.1152/physrev.00034.2003.
PubMed 15269335American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
PubMed 15817806Bult H, Boeckxstaens GE, Pelckmans PA, Jordaens FH, Van Maercke YM, Herman AG. Nitric oxide as an inhibitory non-adrenergic non-cholinergic neurotransmitter. Nature. 1990 May 24;345(6273):346-7. doi: 10.1038/345346a0.
PubMed 1971425Anderson SD, Daviskas E. The airway microvasculature and exercise induced asthma. Thorax. 1992 Sep;47(9):748-52. doi: 10.1136/thx.47.9.748.
PubMed 1440473Scollo M, Zanconato S, Ongaro R, Zaramella C, Zacchello F, Baraldi E. Exhaled nitric oxide and exercise-induced bronchoconstriction in asthmatic children. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):1047-50. doi: 10.1164/ajrccm.161.3.9905043.
PubMed 10712361Buchvald F, Hermansen MN, Nielsen KG, Bisgaard H. Exhaled nitric oxide predicts exercise-induced bronchoconstriction in asthmatic school children. Chest. 2005 Oct;128(4):1964-7. doi: 10.1378/chest.128.4.1964.
PubMed 16236842Terada A, Fujisawa T, Togashi K, Miyazaki T, Katsumata H, Atsuta J, Iguchi K, Kamiya H, Togari H. Exhaled nitric oxide decreases during exercise-induced bronchoconstriction in children with asthma. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1879-84. doi: 10.1164/ajrccm.164.10.2009105.
PubMed 11734440Nishio K, Odajima H, Motomura C, Nakao F, Nishima S. Exhaled nitric oxide and exercise-induced bronchospasm assessed by FEV1, FEF25-75% in childhood asthma. J Asthma. 2007 Jul-Aug;44(6):475-8. doi: 10.1080/02770900701424090.
PubMed 17654135Garcia-Rio F, Ramirez M, Mediano O, Lores V, Rojo B, Villasante C, Villamor J. Exhaled nitric oxide and airway caliber during exercise-induced bronchoconstriction. Int J Sports Med. 2006 Nov;27(11):905-10. doi: 10.1055/s-2006-923775.
PubMed 17120347
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Measuring Exhaled Nitric Oxide in Exercise-Induced Asthma
- ClinicalTrials.gov ID
- NCT01097954
- Acronym / sponsor ID
- 146548
- Conditions
- Exercise Induced Asthma
- Keywords
- Exercise induced asthma, Exercise induced bronchospasm, exhaled Nitric Oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Apr 2010 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subject with symptoms consistent with exercise induced asthma
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Correlation between level of FeNO and reduction in FEV1
Time frame: 1 year
Correlation between level of FeNO and severity of symptoms
Time frame: 1 year
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 13 Feb 2023.
- Background: PubMed 18554705Anderson SD, Kippelen P. Airway injury as a mechanism for exercise-induced bronchoconstriction in elite athletes. J Allergy Clin Immunol. 2008 Aug;122(2):225-35; quiz 236-7. doi: 10.1016/j.jaci.2008.05.001. Epub 2008 Jun 12.
- Background: PubMed 8730329Sue-Chu M, Larsson L, Bjermer L. Prevalence of asthma in young cross-country skiers in central Scandinavia: differences between Norway and Sweden. Respir Med. 1996 Feb;90(2):99-105. doi: 10.1016/s0954-6111(96)90206-1.
- Background: PubMed 12166573Baraldi E, de Jongste JC; European Respiratory Society/American Thoracic Society (ERS/ATS) Task Force. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37. doi: 10.1183/09031936.02.00293102.
- Background: PubMed 15269335Ricciardolo FL, Sterk PJ, Gaston B, Folkerts G. Nitric oxide in health and disease of the respiratory system. Physiol Rev. 2004 Jul;84(3):731-65. doi: 10.1152/physrev.00034.2003.
- Background: PubMed 15817806American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
- Background: PubMed 1971425Bult H, Boeckxstaens GE, Pelckmans PA, Jordaens FH, Van Maercke YM, Herman AG. Nitric oxide as an inhibitory non-adrenergic non-cholinergic neurotransmitter. Nature. 1990 May 24;345(6273):346-7. doi: 10.1038/345346a0.
- Background: PubMed 1440473Anderson SD, Daviskas E. The airway microvasculature and exercise induced asthma. Thorax. 1992 Sep;47(9):748-52. doi: 10.1136/thx.47.9.748.
- Results publication: PubMed 10712361Scollo M, Zanconato S, Ongaro R, Zaramella C, Zacchello F, Baraldi E. Exhaled nitric oxide and exercise-induced bronchoconstriction in asthmatic children. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):1047-50. doi: 10.1164/ajrccm.161.3.9905043.
- Results publication: PubMed 16236842Buchvald F, Hermansen MN, Nielsen KG, Bisgaard H. Exhaled nitric oxide predicts exercise-induced bronchoconstriction in asthmatic school children. Chest. 2005 Oct;128(4):1964-7. doi: 10.1378/chest.128.4.1964.
- Results publication: PubMed 11734440Terada A, Fujisawa T, Togashi K, Miyazaki T, Katsumata H, Atsuta J, Iguchi K, Kamiya H, Togari H. Exhaled nitric oxide decreases during exercise-induced bronchoconstriction in children with asthma. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1879-84. doi: 10.1164/ajrccm.164.10.2009105.
- Results publication: PubMed 17654135Nishio K, Odajima H, Motomura C, Nakao F, Nishima S. Exhaled nitric oxide and exercise-induced bronchospasm assessed by FEV1, FEF25-75% in childhood asthma. J Asthma. 2007 Jul-Aug;44(6):475-8. doi: 10.1080/02770900701424090.
- Results publication: PubMed 17120347Garcia-Rio F, Ramirez M, Mediano O, Lores V, Rojo B, Villasante C, Villamor J. Exhaled nitric oxide and airway caliber during exercise-induced bronchoconstriction. Int J Sports Med. 2006 Nov;27(11):905-10. doi: 10.1055/s-2006-923775.
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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.
Melodi Pirzada, MD principal investigator
Winthrop University Hospital
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 Exercise Induced Asthma, run by Winthrop University Hospital 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 1 inclusion and 5 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 13 Feb 2023. 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?
Variations in the fraction of exhaled nitric oxide in subjects with exercise induced asthma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097954, which also lists 12 linked publications.
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 13 Feb 2023.