Overview

This trial is active, not recruiting.

Condition asthma
Treatment sodium chloride inhalation
Phase phase 2
Sponsor The Hospital for Sick Children
Start date November 2009
End date September 2016
Trial size 49 participants
Trial identifier NCT01095354, 1000013927

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Spirometry. Bronchodilator with Salbutamol. Induced sputum in > 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW).
sodium chloride inhalation Salt, NaCl
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.

Primary Outcomes

Measure
Lung Clearance Index (LCI)
time frame: Day 1

Secondary Outcomes

Measure
Correlation of sputum cell counts with LCI
time frame: Day 1
Effect of bronchodilator on baseline and post-spirometry LCI
time frame: Day 1

Eligibility Criteria

Male or female participants from 3 years up to 18 years old.

Inclusion Criteria: - Asthma Subjects: - 3 - 18 years of age at enrolment - Clinically stable at enrolment - Physician diagnosis of asthma and attending follow-up in the Asthma Clinic Exclusion Criteria: - Asthma Subjects: - Born premature (before 37 weeks gestational age) - Low birth weight (less than 2.5 kilograms) - History of congenital heart disease, neuromuscular disorder or bone disease - History of any chronic lung disease other than asthma - Respiratory infection in last three weeks - Change in medication in last three weeks (including oral steroids) - Current or previous history of smoking

Additional Information

Official title Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma
Principal investigator Padmaja Subbarao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.