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

NCT01090557 | Completed DMC

• 1 other identifier: 07029
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

RSV Infection; Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness

  2 years

• FeNO levels in viral respiratory illness will vary with steroid use

  2 years

Study Arms (3)

RSV positive subjects

Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are positive for RSV by Direct Fluorescent Antibody technique and/or viral culture

Other: Collection of exhaled breath

RSV negative subjects

Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are negative for RSV by Direct Fluorescent Antibody technique and/or viral culture (usually positive for influenza A \& B, parainfluenza, human metapneumovirus or adenovirus)

Other: Collection of exhaled breath

Control group

Children with same age range, ethnic background, and gender distribution as the study group coming for evaluation in the outpatient setting without evidence of viral infection

Other: Collection of exhaled breath

Interventions

Collection of exhaled breath OTHER

balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement

Control group; RSV negative subjects; RSV positive subjects

Eligibility Criteria

• Age: 1 Day - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The parents of children admitted to WUH with a diagnosis of lower respiratory tract viral illness (LRTVI) will be offered the opportunity to participate

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related 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. doi: 10.1164/rccm.200406-710ST. No abstract available.

  PMID: 15817806 BACKGROUND

• 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. doi: 10.1183/09031936.02.00293102.

  PMID: 12166573 BACKGROUND

• 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. doi: 10.1080/00016480252775751.

  PMID: 11876601 BACKGROUND

• 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. doi: 10.1152/physrev.00034.2003.

  PMID: 15269335 BACKGROUND

• 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. doi: 10.1164/ajrccm.163.2.9912068.

  PMID: 11179135 BACKGROUND

• 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. doi: 10.1164/ajrccm.159.4.9807084.

  PMID: 10194178 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Bronchiolitis

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Maria L Quintos-Alagheband, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: March 22, 2010
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 22, 2010

Record last verified: 2010-03

Locations

US (1)