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Clinical Trials/NCT01095354
NCT01095354
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country49 target enrollmentNovember 2009
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Sodium Chloride Inhalation
Conditions
Asthma
Sponsor
The Hospital for Sick Children
Enrollment
49
Locations
1
Primary Endpoint
Lung Clearance Index (LCI)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
May 23, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Padmaja Subbarao

Staff Respirologist

The Hospital for Sick Children

Eligibility Criteria

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

Arms & Interventions

Asthma Patients

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

Intervention: Sodium Chloride Inhalation

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Correlation of sputum cell counts with LCI(Day 1)
  • Effect of bronchodilator on baseline and post-spirometry LCI(Day 1)

Study Sites (1)

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