Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma
|ClinicalTrials.gov Identifier: NCT01095354|
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment|
|Asthma||Drug: Sodium Chloride Inhalation|
|Study Type :||Observational|
|Actual Enrollment :||49 participants|
|Official Title:||Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 23, 2018|
Spirometry. Bronchodilator with Salbutamol. Induced sputum in > 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW).
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.
Other Name: Salt, NaCl
- Lung Clearance Index (LCI) [ Time Frame: Day 1 ]Lung clearance index will be compared between healthy and asthmatic patients after they have performed Pulmonary Function Testing and Multiple Breath Washout
- Correlation of sputum cell counts with LCI [ Time Frame: Day 1 ]Sputum induction for specimen collection
- Effect of bronchodilator on baseline and post-spirometry LCI [ Time Frame: Day 1 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095354
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Padmaja Subbarao, MD||The Hospital for Sick Children|