AsthmaNCT01095354
Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma
An observational study of Asthma, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Sodium Chloride Inhalation
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to 23 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Sodium Chloride Inhalation
- Keywords
- pediatric, lung ventilation inhomogeneity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride InhalationDrug
Also called Salt, NaCl
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.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Patients | Spirometry. Bronchodilator with Salbutamol. Induced sputum in > 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW). Receives: Drug: Sodium Chloride Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
Correlation of sputum cell counts with LCI
Sputum induction for specimen collection
Measured: Day 1
Effect of bronchodilator on baseline and post-spirometry LCI
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2015
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padmaja Subbarao, The Hospital for Sick Children
- Investigators
- Padmaja Subbarao, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095354
- Sponsor's protocol ID
- 1000013927
- Status last verified
- Jun 2018
- First submitted
- 23 Mar 2010
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: scientific journal articles
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lung Ventilation Inhomogeneity in Pediatric Asthma: Multiple Breath Washout and Asthma
- ClinicalTrials.gov ID
- NCT01095354
- Acronym / sponsor ID
- 1000013927
- Conditions
- Asthma
- Keywords
- pediatric, lung ventilation inhomogeneity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Patients | – | Drug: Sodium Chloride InhalationSpirometry. Bronchodilator with Salbutamol. Induced sputum in > 10 years of age using Sodium Chloride Inhalation. Multiple Breath Washout (MBW). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- Asthma Subjects:
Key exclusion criteria (8 listed)
- Asthma Subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride InhalationAlso: Salt, NaClSpirometry: 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. | Drug | Asthma Patients |
Primary outcome
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
2 secondary outcomes
Correlation of sputum cell counts with LCI
Time frame: Day 1
Effect of bronchodilator on baseline and post-spirometry LCI
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: Yes. scientific journal articles
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padmaja Subbarao, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Clearance Index (LCI) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.