AsthmaNCT00575445
The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients
An observational study of Asthma, run by Akron Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2015
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric pulmonary clinic
Who may be able to join
- Clinical diagnosis of asthma by pediatric pulmonologist
- Age 6-18 years
Who cannot join
- Age <6 years or >18 years
- history of bronchopulmonary dysplasia
- history of cystic fibrosis
- history of primary ciliary dyskinesia
- current acute asthma exacerbation
- current acute viral upper respiratory infection
- recent ingestion of nitrate-rich foods
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). During the study the investigators will also examine if the combination of eNO and ACT will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pediatric patients with previously diagnosed asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled nitric oxide level
Measured: One office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionMar 2015
Why it stopped: Nitric Oxide analyzer not functioning properly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tiffany L Turner, MD, Principal investigator, Pediatric resident at Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575445
- Sponsor's protocol ID
- eNO/ACT Study
- Status last verified
- Mar 2015
- First submitted
- 14 Dec 2007
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyts I, Proesmans M, De Boeck K. Exhaled nitric oxide corresponds with office evaluation of asthma control. Pediatr Pulmonol. 2003 Oct;36(4):283-9. doi: 10.1002/ppul.10317.
PubMed 12950039Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PubMed 14713908Olin AC, Aldenbratt A, Ekman A, Ljungkvist G, Jungersten L, Alving K, Toren K. Increased nitric oxide in exhaled air after intake of a nitrate-rich meal. Respir Med. 2001 Feb;95(2):153-8. doi: 10.1053/rmed.2000.1010.
PubMed 11217912Malinovschi A, Janson C, Holmkvist T, Norback D, Merilainen P, Hogman M. Effect of smoking on exhaled nitric oxide and flow-independent nitric oxide exchange parameters. Eur Respir J. 2006 Aug;28(2):339-45. doi: 10.1183/09031936.06.00113705. Epub 2006 Apr 26.
PubMed 16641119Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PubMed 17353040Lara M, Duan N, Sherbourne C, Lewis MA, Landon C, Halfon N, Brook RH. Differences between child and parent reports of symptoms among Latino children with asthma. Pediatrics. 1998 Dec;102(6):E68. doi: 10.1542/peds.102.6.e68.
PubMed 9832596Klein RB, Fritz GK, Yeung A, McQuaid EL, Mansell A. Spirometric patterns in childhood asthma: peak flow compared with other indices. Pediatr Pulmonol. 1995 Dec;20(6):372-9. doi: 10.1002/ppul.1950200607.
PubMed 8649917Hoek G, Wypij D, Brunekreef B. Self-reporting versus parental reporting of acute respiratory symptoms of children and their relation to pulmonary function and air pollution. Int J Epidemiol. 1999 Apr;28(2):293-9. doi: 10.1093/ije/28.2.293.
PubMed 10342694Grasemann H, Schwiertz R, Matthiesen S, Racke K, Ratjen F. Increased arginase activity in cystic fibrosis airways. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1523-8. doi: 10.1164/rccm.200502-253OC. Epub 2005 Sep 15.
PubMed 16166623Franklin PJ, Turner SW, Mutch RC, Stick SM. Measuring exhaled nitric oxide in infants during tidal breathing: methodological issues. Pediatr Pulmonol. 2004 Jan;37(1):24-30. doi: 10.1002/ppul.10382.
PubMed 14679485Dupont LJ, Demedts MG, Verleden GM. Prospective evaluation of the validity of exhaled nitric oxide for the diagnosis of asthma. Chest. 2003 Mar;123(3):751-6. doi: 10.1378/chest.123.3.751.
PubMed 12628874Corbelli R, Bringolf-Isler B, Amacher A, Sasse B, Spycher M, Hammer J. Nasal nitric oxide measurements to screen children for primary ciliary dyskinesia. Chest. 2004 Oct;126(4):1054-9. doi: 10.1378/chest.126.4.1054.
PubMed 15486363Baraldi E, Bonetto G, Zacchello F, Filippone M. Low exhaled nitric oxide in school-age children with bronchopulmonary dysplasia and airflow limitation. Am J Respir Crit Care Med. 2005 Jan 1;171(1):68-72. doi: 10.1164/rccm.200403-298OC. Epub 2004 Oct 11.
PubMed 15477497Antus B, Csiszer E, Czebe K, Horvath I. Pulmonary infections increase exhaled nitric oxide in lung transplant recipients: a longitudinal study. Clin Transplant. 2005 Jun;19(3):377-82. doi: 10.1111/j.1399-0012.2005.00354.x.
PubMed 15877802
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00575445
- Acronym / sponsor ID
- eNO/ACT Study
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Nitric Oxide analyzer not functioning properly
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Dec 2007 (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.
The purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). During the study the investigators will also examine if the combination of eNO and ACT will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pediatric patients with previously diagnosed asthma |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric pulmonary clinic
Key inclusion criteria (2 listed)
- Clinical diagnosis of asthma by pediatric pulmonologist
- Age 6-18 years
Key exclusion criteria (7 listed)
- Age <6 years or >18 years
- history of bronchopulmonary dysplasia
- history of cystic fibrosis
- history of primary ciliary dyskinesia
- current acute asthma exacerbation
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
Exhaled nitric oxide level
Time frame: One office visit
Results and safety
The study was stopped early (reason given: Nitric Oxide analyzer not functioning properly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 12950039Meyts I, Proesmans M, De Boeck K. Exhaled nitric oxide corresponds with office evaluation of asthma control. Pediatr Pulmonol. 2003 Oct;36(4):283-9. doi: 10.1002/ppul.10317.
- Background: PubMed 14713908Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
- Background: PubMed 11217912Olin AC, Aldenbratt A, Ekman A, Ljungkvist G, Jungersten L, Alving K, Toren K. Increased nitric oxide in exhaled air after intake of a nitrate-rich meal. Respir Med. 2001 Feb;95(2):153-8. doi: 10.1053/rmed.2000.1010.
- Background: PubMed 16641119Malinovschi A, Janson C, Holmkvist T, Norback D, Merilainen P, Hogman M. Effect of smoking on exhaled nitric oxide and flow-independent nitric oxide exchange parameters. Eur Respir J. 2006 Aug;28(2):339-45. doi: 10.1183/09031936.06.00113705. Epub 2006 Apr 26.
- Background: PubMed 17353040Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
- Background: PubMed 9832596Lara M, Duan N, Sherbourne C, Lewis MA, Landon C, Halfon N, Brook RH. Differences between child and parent reports of symptoms among Latino children with asthma. Pediatrics. 1998 Dec;102(6):E68. doi: 10.1542/peds.102.6.e68.
- Background: PubMed 8649917Klein RB, Fritz GK, Yeung A, McQuaid EL, Mansell A. Spirometric patterns in childhood asthma: peak flow compared with other indices. Pediatr Pulmonol. 1995 Dec;20(6):372-9. doi: 10.1002/ppul.1950200607.
- Background: PubMed 10342694Hoek G, Wypij D, Brunekreef B. Self-reporting versus parental reporting of acute respiratory symptoms of children and their relation to pulmonary function and air pollution. Int J Epidemiol. 1999 Apr;28(2):293-9. doi: 10.1093/ije/28.2.293.
- Background: PubMed 16166623Grasemann H, Schwiertz R, Matthiesen S, Racke K, Ratjen F. Increased arginase activity in cystic fibrosis airways. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1523-8. doi: 10.1164/rccm.200502-253OC. Epub 2005 Sep 15.
- Background: PubMed 14679485Franklin PJ, Turner SW, Mutch RC, Stick SM. Measuring exhaled nitric oxide in infants during tidal breathing: methodological issues. Pediatr Pulmonol. 2004 Jan;37(1):24-30. doi: 10.1002/ppul.10382.
- Background: PubMed 12628874Dupont LJ, Demedts MG, Verleden GM. Prospective evaluation of the validity of exhaled nitric oxide for the diagnosis of asthma. Chest. 2003 Mar;123(3):751-6. doi: 10.1378/chest.123.3.751.
- Background: PubMed 15486363Corbelli R, Bringolf-Isler B, Amacher A, Sasse B, Spycher M, Hammer J. Nasal nitric oxide measurements to screen children for primary ciliary dyskinesia. Chest. 2004 Oct;126(4):1054-9. doi: 10.1378/chest.126.4.1054.
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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.
Tiffany L Turner, MD principal investigator
Pediatric resident at Akron Children's 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 Asthma, run by Akron Children's 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Mar 2015. 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 was stopped early (reason given: Nitric Oxide analyzer not functioning properly). Results are not available in the source record.
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?
Exhaled nitric oxide level (time frame: One office visit). 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 NCT00575445, which also lists 14 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 25 Mar 2015.