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Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01095354
Enrollment
49
Registered
2010-03-30
Start date
2009-11-30
Completion date
2018-05-23
Last updated
2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

pediatric, lung ventilation inhomogeneity

Brief 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.

Interventions

DRUGSodium 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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lung Clearance Index (LCI)Day 1Lung clearance index will be compared between healthy and asthmatic patients after they have performed Pulmonary Function Testing and Multiple Breath Washout

Secondary

MeasureTime frameDescription
Correlation of sputum cell counts with LCIDay 1Sputum induction for specimen collection
Effect of bronchodilator on baseline and post-spirometry LCIDay 1

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026