Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

Completed

• Conditions: Asthma
• Interventions: Drug: Sodium Chloride Inhalation

• Registration Number: NCT01095354
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2015-05
• Study Completion: 2018-05-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asthma Patients	Sodium Chloride Inhalation	Spirometry. Bronchodilator with Salbutamol. Induced sputum in \> 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of sputum cell counts with LCI	Day 1	Sputum induction for specimen collection
Effect of bronchodilator on baseline and post-spirometry LCI	Day 1

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada