Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095354
• Other study ID #: 1000013927
• Status: Completed
• Start date: November 2009
• Est. completion date: May 23, 2018

Study information

• Verified date: June 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 23, 2018
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Clearance Index (LCI)	Lung clearance index will be compared between healthy and asthmatic patients after they have performed Pulmonary Function Testing and Multiple Breath Washout	Day 1
Secondary	Correlation of sputum cell counts with LCI	Sputum induction for specimen collection	Day 1
Secondary	Effect of bronchodilator on baseline and post-spirometry LCI		Day 1

External Links

•   Published Article