The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients

Asthma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00575445
• Other study ID #: eNO/ACT Study
• Status: Terminated
• Phase: N/A
• First received: December 14, 2007
• Last updated: March 24, 2015
• Start date: November 2007
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of asthma by pediatric pulmonologist

• Age 6-18 years

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (14)

Antus 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. — View Citation

Baraldi 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. Epub 2004 Oct 11. — View Citation

Corbelli 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. — View Citation

Dupont 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. — View Citation

Franklin 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. — View Citation

Grasemann H, Schwiertz R, Matthiesen S, Racké K, Ratjen F. Increased arginase activity in cystic fibrosis airways. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1523-8. Epub 2005 Sep 15. — View Citation

Hoek 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. — View Citation

Klein 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. — View Citation

Lara 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. — View Citation

Liu 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. Epub 2007 Mar 13. — View Citation

Malinovschi A, Janson C, Holmkvist T, Norbäck D, Meriläinen P, Högman M. Effect of smoking on exhaled nitric oxide and flow-independent nitric oxide exchange parameters. Eur Respir J. 2006 Aug;28(2):339-45. Epub 2006 Apr 26. — View Citation

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. — View Citation

Nathan 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. — View Citation

Olin AC, Aldenbratt A, Ekman A, Ljungkvist G, Jungersten L, Alving K, Torén K. Increased nitric oxide in exhaled air after intake of a nitrate-rich meal. Respir Med. 2001 Feb;95(2):153-8. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled nitric oxide level		One office visit	No