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Completed

NCT Number: NCT01095354

Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Salt, NaCl

Primary outcomes

  1. 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

  1. Correlation of sputum cell counts with LCI

    Time frame: Day 1

    Sputum induction for specimen collection

  2. Effect of bronchodilator on baseline and post-spirometry LCI

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2018
First posted
Mar 30, 2010
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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