NCT01095354

Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine if well-controlled asthmatic patients followed in subspecialty asthma clinics between the ages of 3 - 18 years can be distinguished from healthy controls using lung clearance index, a parameter from the multiple breath washout test. Also, to correlate lung clearance index with asthma sputum cell counts.

Detailed description

Clinical studies are underway which are examining the utility of the LCI in obstructive respiratory disease (cystic fibrosis and asthma). However, the majority of studies have examined asthmatics with ongoing evidence of reversible disease on spirometry. There is a very limited body of research comparing LCI values in well-controlled asthmatics to healthy controls. Furthermore, the type of inflammation occurring in asthma may have a different site of action, we will prospectively study whether there is a difference in LCI between eosinophilic and neutrophilic inflammation to give us an indication of whether the site of non-eosinophilic inflammation is primarily in the small airways as well.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Sodium Chloride Inhalation	Spirometry: all subjects Plethysmography and exhaled nitric oxide: \>6 years Multiple Breath Washout: Tidal breathing using a facemask \<9 years or mouthpiece \>9 years. Wash-in phase: gas mixture containing 4% SF6, 4% He, 21% oxygen and balance nitrogen inhaled until steady state. Bias flow stopped during expiration by removal of T-piece. Wash-out phase: patient inspires room air and exhales tracer gas until SF6 reaches \<0.1%. Bronchodilator response: Bronchodilator (Salbutamol 400 mcg) to asthma subjects, spirometry and MBW repeated after 15 minutes. Induced sputum in asthma subjects \>10 yrs. Post-bronchodilator spirometry, subject inhales concentrations of 3, 4 and 5% hypertonic saline for 7 minutes for 3 cycles until expectorating sputum.

Timeline

• Start date: 2009-11-01
• Primary completion: 2015-05-01
• Completion: 2018-05-23
• First posted: 2010-03-30
• Last updated: 2018-06-29

Locations

1 site across 1 country: Canada