An interventional study of Methacholine Chloride and Trudell AeroEclipse*II BAN nebulizer in Asthma, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
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.
McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The English-Wright nebulizer will be used to perform a methacholine challenge.
Drug: Methacholine Chloride · Device: The English-Wright nebulizer
The Trudell AeroEclipse\*II BAN nebulizer will be used to perform a methacholine challenge
Drug: Methacholine Chloride · Device: Trudell AeroEclipse*II BAN nebulizer
Choline ester that acts as a non-selective muscarinic receptor agonist in the parasympathetic nervous system Low risk - commonly used to diagnose asthma
Generates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value
Continuous-mode nebuilzer, designed to operate continuously with tidal breathing Roxon Medi-Tech, Montreal, PQ, Canada
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.
Time frame: 2 weeks
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McMaster University