Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study

Bronchiolitis Clinical Trial

Official title:

A Prospective, Pilot Study Measuring Exhaled Nitric Oxide Levels in Infants and Young Children Admitted to the Hospital for Respiratory Syncytial Virus (RSV) or Other Viral Lower Respiratory Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090557
• Other study ID #: 07029
• Status: Completed
• Phase: N/A
• First received: October 6, 2009
• Last updated: March 19, 2010
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2010
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV.

The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness and to determine if there is a difference in feNO level between RSV and non-RSV infection.

NO may play a role in the association between RSV, airway reactivity, and airway inflammation.

This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years of age admitted to Winthrop University Hospital, as well as controls (children in the same age range without respiratory conditions and who are well enough to perform the test). Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) & DFA) and via direct fluorescent antigen technique (DFA) for influenza A & B, parainfluenza, human metapneumovirus and adenovirus.

Method of feNO measurement will utilize the offline options for preschool children & infants appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society & the European Respiratory Society when discussing tidal breathing techniques with uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.

The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Years

Eligibility

Inclusion Criteria:

• Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection

Exclusion Criteria:

• asthma/RAD

• recurrent wheezing

• "recurrent bronchiolitis"

• allergic rhinitis

• atopy

• 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

• interstitial lung

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• RSV Infection

Intervention

Other:
• Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

American 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. — View Citation

Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8. — View Citation

Baraldi 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. — View Citation

Gentile DA, Doyle WJ, Belenky S, Ranck H, Angelini B, Skoner DP. Nasal and oral nitric oxide levels during experimental respiratory syncytial virus infection of adults. Acta Otolaryngol. 2002 Jan;122(1):61-6. — View Citation

Kao YJ, Piedra PA, Larsen GL, Colasurdo GN. Induction and regulation of nitric oxide synthase in airway epithelial cells by respiratory syncytial virus. Am J Respir Crit Care Med. 2001 Feb;163(2):532-9. — View Citation

Ricciardolo 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects		2 years	No
Secondary	FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness		2 years	No
Secondary	FeNO levels in viral respiratory illness will vary with steroid use		2 years	No