Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

NCT01095354 | Completed

• 1 other identifier: 1000013927
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

pediatric; lung ventilation inhomogeneity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation of sputum cell counts with LCI

  Day 1

• Effect of bronchodilator on baseline and post-spirometry LCI

  Day 1

Study Arms (1)

Asthma Patients

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

Drug: Sodium Chloride Inhalation

Interventions

Sodium Chloride Inhalation DRUG

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.

Also known as: Salt, NaCl

Asthma Patients

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asthma patients will be recruited from the Respiratory Medicine clinic at the Hospital for Sick Children. A member of the medical team in the Asthma Clinic, known to the patient, will introduce the study, and obtain permission for the patient/caregiver to meet with study personnel. Subjects will then be approached by the Principal investigator or her delegate. They will be informed that enrolment is voluntary and that they can withdraw from the study at any time.

You may qualify if:

• Asthma Subjects:
• years of age at enrolment
• Clinically stable at enrolment
• Physician diagnosis of asthma and attending follow-up in the Asthma Clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples will be processed and divided into two categories: eosinophilic (% eosinophils \>2.5%) and non-eosinophilic (\<2.5% eosinophils). The two categories of asthmatics will be used to categorize asthmatics for comparison on parameters such as SnIII analysis of SF6, LCI etc. In addition, % eosinophilia will be considered as a continuous measure in those with % eosinophils \> 2% and correlated with LCI.

MeSH Terms

Conditions

Asthma

Interventions

Salts

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Padmaja Subbarao, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Respirologist

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 30, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 23, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)