AsthmaNCT01919424
Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer
A study testing Methacholine Chloride, Trudell AeroEclipse*II BAN nebulizer and The English-Wright nebulizer in people with Asthma, run by McMaster University at 1 site in Canada.
Trial summary
This study will compare the methacholine PC20 of two different modern-delivery aerosol systems to determine if one may replace the other for use in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine Chloride, Trudell AeroEclipse*II BAN nebulizer and The English-Wright nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Oct 2013
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with stable asthma.
- Tidal breathing PC20≤16 mg/mL.
- Baseline FEV1 more than 65% of predicted normal.
- Able to complete 3 methacholine challenges on 3 separate days at the same time of day, at least 24-hours apart and within a 2-week period. (1 during screening and the other 2 during the study)
Who cannot join
- Airway infection or allergen exposure during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Change in dosage of inhaled or oral steroids during the last 4 weeks.
- Inhaled salbutamol less than 8 hours prior to testing.
- Inhaled formoterol or salmeterol less than 36 hours prior to testing.
- Antihistamines during the last 48 hours.
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- Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).
- Smokers
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, L8N 3Z5
About this study
This study will compare the methacholine PC20 of two different modern-delivery aerosol systems to determine if one may replace the other for use in clinical settings.
Read the detailed description
Thirty three asthmatic subjects (>18 years, both sexes) who have stable asthma will be recruited to undergo methacholine challenges for a randomized, crossover, observational study. The objective of this study is to compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. Subjects will inhale methacholine using both nebulizing systems on separate visits and the PC20 values will be compared. The results from these experiments will give us a better indication of whether the modern AeroEclipse* II BAN nebulizer might be sufficient to replace the current "gold standard" Wright nebulizer in clinical settings.
Baseline Spirometry
Baseline FEV1 and VC will be registered using an electronic spirometer meeting ATS requirements.
Screening
A medical history will be conducted by interview and asthma medications will be reviewed on this V1. Subjects will also undergo a Methacholine Challenge to determine their PC20 and therefore their eligibility into the study.
Methacholine Challenge
Challenges will be carried out after a minimum 8-hour washout of short-acting ß2-agonist. Subjects will perform methacholine challenges on 2 separate days at the same time of day, at least 24-hours apart and all within a 2-week period. At V2, subjects will be randomly assigned to use either the Wright nebulizer or the AeroEclipse*II BAN nebulizer. Methacholine inhalation from the Wright nebulizer will be performed as follows. Subjects are instructed to wear noseclips and to breathe normally from the mouthpiece during the 2-minute inhalation period. Subjects inhale normal saline, then doubling concentrations of methacholine for 2 minutes each always starting at a dose of 0.03 mg/ml. Spirometry is measured with an electronic spirometer meeting ATS requirements. FEV1 is measured at 30 and 90 seconds after each inhalation and the highest FEV1 will be used to calculate the % fall from baseline. There is a 3 minute interval between the end of one inhalation dose and start of the next inhalation dose. The test is terminated when a fall in FEV1 of 20% of the baseline value occurs and the methacholine PC20 is calculated. The same protocol will be applied to methacholine inhalation using the AeroEclipse*II BAN nebulizer with the exception that the 2-minute tidal breathing will be reduced to 20 seconds and the interval between the end of one inhalation dose and start of the next inhalation dose is 3 minutes and 40 seconds. Subjects will return to the lab on V3 to complete a methacholine challenge using the alternate nebulizer from the one used on V2.
DATA ANALYSIS
The methacholine PC20 values will be log-transformed before performing summary statistics. The PC20 values will be compared by paired t-test.
- Conditions
- Asthma
- Being tested
- Methacholine Chloride, Trudell AeroEclipse*II BAN nebulizer, The English-Wright nebulizer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine ChlorideDrug
Choline ester that acts as a non-selective muscarinic receptor agonist in the parasympathetic nervous system
Low risk - commonly used to diagnose asthma
Trudell AeroEclipse*II BAN nebulizerDevice
Generates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value
The English-Wright nebulizerDevice
Continuous-mode nebuilzer, designed to operate continuously with tidal breathing
Roxon Medi-Tech, Montreal, PQ, Canada
| Study group | Role | What they receive |
|---|---|---|
| 'The English-Wright nebulizer' | Active comparator | The English-Wright nebulizer will be used to perform a methacholine challenge. Receives: Drug: Methacholine Chloride; Device: The English-Wright nebulizer |
| Trudell AeroEclipse*II BAN nebulizer | Active comparator | The Trudell AeroEclipse*II BAN nebulizer will be used to perform a methacholine challenge Receives: Drug: Methacholine Chloride; Device: Trudell AeroEclipse*II BAN nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PC20 of two different aerosol systems
To compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. FEV1 is measured by spirometry following inhalation of increasing concentrations of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Gauvreau, McMaster University
- Investigators
- Gail Gauvreau, PhD, Principal investigator, Study investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919424
- Sponsor's protocol ID
- HIREB 11-004
- Status last verified
- Apr 2015
- First submitted
- 2 Aug 2013
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Gammal AI, Killian KJ, Scime TX, Beaudin S, Schlatman A, Cockcroft DW, Gauvreau GM. Comparison of the provocative concentration of methacholine causing a 20% fall in FEV1 between the AeroEclipse II breath-actuated nebulizer and the wright nebulizer in adult subjects with asthma. Ann Am Thorac Soc. 2015 Jul;12(7):1039-43. doi: 10.1513/AnnalsATS.201412-571BC.
PubMed 25871542
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer
- ClinicalTrials.gov ID
- NCT01919424
- Acronym / sponsor ID
- HIREB 11-004
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Aug 2013 (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.
This study will compare the methacholine PC20 of two different modern-delivery aerosol systems to determine if one may replace the other for use in clinical settings.
Detailed description
Thirty three asthmatic subjects (>18 years, both sexes) who have stable asthma will be recruited to undergo methacholine challenges for a randomized, crossover, observational study. The objective of this study is to compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. Subjects will inhale methacholine using both nebulizing systems on separate visits and the PC20 values will be compared. The results from these experiments will give us a better indication of whether the modern AeroEclipse* II BAN nebulizer might be sufficient to replace the current "gold standard" Wright nebulizer in clinical settings.
Baseline Spirometry
Baseline FEV1 and VC will be registered using an electronic spirometer meeting ATS requirements.
Screening
A medical history will be conducted by interview and asthma medications will be reviewed on this V1. Subjects will also undergo a Methacholine Challenge to determine their PC20 and therefore their eligibility into the study.
Methacholine Challenge
Challenges will be carried out after a minimum 8-hour washout of short-acting ß2-agonist. Subjects will perform methacholine challenges on 2 separate days at the same time of day, at least 24-hours apart and all within a 2-week period. At V2, subjects will be randomly assigned to use either the Wright nebulizer or the AeroEclipse*II BAN nebulizer. Methacholine inhalation from the Wright nebulizer will be performed as follows. Subjects are instructed to wear noseclips and to breathe normally from the mouthpiece during the 2-minute inhalation period. Subjects inhale normal saline, then doubling concentrations of methacholine for 2 minutes each always starting at a dose of 0.03 mg/ml. Spirometry is measured with an electronic spirometer meeting ATS requirements. FEV1 is measured at 30 and 90 seconds after each inhalation and the highest FEV1 will be used to calculate the % fall from baseline. There is a 3 minute interval between the end of one inhalation dose and start of the next inhalation dose. The test is terminated when a fall in FEV1 of 20% of the baseline value occurs and the methacholine PC20 is calculated. The same protocol will be applied to methacholine inhalation using the AeroEclipse*II BAN nebulizer with the exception that the 2-minute tidal breathing will be reduced to 20 seconds and the interval between the end of one inhalation dose and start of the next inhalation dose is 3 minutes and 40 seconds. Subjects will return to the lab on V3 to complete a methacholine challenge using the alternate nebulizer from the one used on V2.
DATA ANALYSIS
The methacholine PC20 values will be log-transformed before performing summary statistics. The PC20 values will be compared by paired t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'The English-Wright nebulizer' | Active comparator | Drug: Methacholine Chloride, Device: The English-Wright nebulizerThe English-Wright nebulizer will be used to perform a methacholine challenge. |
| Trudell AeroEclipse*II BAN nebulizer | Active comparator | Drug: Methacholine Chloride, Device: Trudell AeroEclipse*II BAN nebulizerThe Trudell AeroEclipse*II BAN nebulizer will be used to perform a methacholine challenge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with stable asthma.
- Tidal breathing PC20≤16 mg/mL.
- Baseline FEV1 more than 65% of predicted normal.
- Able to complete 3 methacholine challenges on 3 separate days at the same time of day, at least 24-hours apart and within a 2-week period. (1 during screening and the other 2 during the study)
Key exclusion criteria (9 listed)
- Airway infection or allergen exposure during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Change in dosage of inhaled or oral steroids during the last 4 weeks.
- Inhaled salbutamol less than 8 hours prior to testing.
- Inhaled formoterol or salmeterol less than 36 hours prior to testing.
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 |
|---|---|---|
| Methacholine ChlorideCholine ester that acts as a non-selective muscarinic receptor agonist in the parasympathetic nervous system Low risk - commonly used to diagnose asthma | Drug | 'The English-Wright nebulizer', Trudell AeroEclipse*II BAN nebulizer |
| Trudell AeroEclipse*II BAN nebulizerGenerates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value | Device | Trudell AeroEclipse*II BAN nebulizer |
| The English-Wright nebulizerContinuous-mode nebuilzer, designed to operate continuously with tidal breathing Roxon Medi-Tech, Montreal, PQ, Canada | Device | 'The English-Wright nebulizer' |
Primary outcome
Methacholine PC20 of two different aerosol systems
Time frame: 2 weeks
To compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. FEV1 is measured by spirometry following inhalation of increasing concentrations of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
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 15 Apr 2015.
- Derived from this study: PubMed 25871542El-Gammal AI, Killian KJ, Scime TX, Beaudin S, Schlatman A, Cockcroft DW, Gauvreau GM. Comparison of the provocative concentration of methacholine causing a 20% fall in FEV1 between the AeroEclipse II breath-actuated nebulizer and the wright nebulizer in adult subjects with asthma. Ann Am Thorac Soc. 2015 Jul;12(7):1039-43. doi: 10.1513/AnnalsATS.201412-571BC.
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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.
Gail Gauvreau, PhD principal investigator
Study investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacholine Chloride, Trudell AeroEclipse*II BAN nebulizer and The English-Wright nebulizer in people with Asthma, run by McMaster University 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 9 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 15 Apr 2015. 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?
Methacholine PC20 of two different aerosol systems (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919424, which also lists 1 linked publication.
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 15 Apr 2015.