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Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma

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ClinicalTrials.gov Identifier: NCT01095354
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Padmaja Subbarao, 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.

Condition or disease Intervention/treatment
Asthma Drug: Sodium Chloride Inhalation

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.

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma
Actual Study Start Date : November 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
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

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 Name: Salt, NaCl




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095354


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Padmaja Subbarao, MD The Hospital for Sick Children

Additional Information:
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Responsible Party: Padmaja Subbarao, Staff Respirologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01095354     History of Changes
Other Study ID Numbers: 1000013927
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: scientific journal articles

Keywords provided by Padmaja Subbarao, The Hospital for Sick Children:
pediatric
lung ventilation inhomogeneity

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents