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

This study is currently recruiting participants.

Verified by Akron Children's Hospital, June 2008

Sponsored by:	Akron Children's Hospital
Information provided by:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT00575445

Purpose

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.

Condition
Asthma

MedlinePlus related topics: Asthma

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:

Exhaled nitric oxide level [ Time Frame: One office visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2008

Groups/Cohorts
1 Pediatric patients with previously diagnosed asthma

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pediatric pulmonary clinic

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575445

Contacts

Contact: Tiffany L Turner, MD

330-554-1863

tturner@neoucom.edu

Locations

United States, Ohio
Akron Children's Hospital	Recruiting
Akron, Ohio, United States, 44308
Principal Investigator: Tiffany L Turner, MD
Sub-Investigator: Kimberly A Spoonhower, MD
Sub-Investigator: Nathan C Kraynack, MD

Sponsors and Collaborators

Akron Children's Hospital

Investigators

Principal Investigator:

Tiffany L Turner, MD

Pediatric resident at Akron Children's Hospital

More Information

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Akron Children's Hospital ( Tiffany Turner, MD/Principal Investigator )
Study ID Numbers:	eNO/ACT Study
Study First Received:	December 14, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00575445
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Nitric Oxide
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009