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

NCT00575445 | Terminated

• 1 other identifier: eNO/ACT Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Exhaled nitric oxide level

  One office visit

Study Arms (1)

1

Pediatric patients with previously diagnosed asthma

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric pulmonary clinic

You may qualify if:

• Clinical diagnosis of asthma by pediatric pulmonologist
• Age 6-18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (14)

• 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.

  PMID: 12950039 BACKGROUND

• 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. doi: 10.1016/j.jaci.2003.09.008.

  PMID: 14713908 BACKGROUND

• Olin 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.

  PMID: 11217912 BACKGROUND

• Malinovschi 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.

  PMID: 16641119 BACKGROUND

• 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. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.

  PMID: 17353040 BACKGROUND

• 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. doi: 10.1542/peds.102.6.e68.

  PMID: 9832596 BACKGROUND

• 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. doi: 10.1002/ppul.1950200607.

  PMID: 8649917 BACKGROUND

• 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. doi: 10.1093/ije/28.2.293.

  PMID: 10342694 BACKGROUND

• Grasemann 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.

  PMID: 16166623 BACKGROUND

• 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. doi: 10.1002/ppul.10382.

  PMID: 14679485 BACKGROUND

• 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. doi: 10.1378/chest.123.3.751.

  PMID: 12628874 BACKGROUND

• 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. doi: 10.1378/chest.126.4.1054.

  PMID: 15486363 BACKGROUND

• 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. doi: 10.1164/rccm.200403-298OC. Epub 2004 Oct 11.

  PMID: 15477497 BACKGROUND

• 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. doi: 10.1111/j.1399-0012.2005.00354.x.

  PMID: 15877802 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tiffany L Turner, MD

  Pediatric resident at Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

US (1)