Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer
NCT ID: NCT01919424
Last Updated: 2015-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
46 participants
INTERVENTIONAL
2011-04-30
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing
NCT02822859
The Effects Of Methacholine Challenge Administered Using Three Different Nebulizers On Small Airways Function
NCT00529477
Assessment of SOLO Vibrating Mesh Nebulizer for Allergen-Induced Late Asthmatic Responses
NCT04630405
AeroEclipse II Agreement
NCT01288482
Investigation of Novel Procedure for Methacholine Challenge Testing
NCT02965482
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
'The English-Wright nebulizer'
The English-Wright nebulizer will be used to perform a methacholine challenge.
Methacholine Chloride
Choline ester that acts as a non-selective muscarinic receptor agonist in the parasympathetic nervous system
Low risk - commonly used to diagnose asthma
The English-Wright nebulizer
Continuous-mode nebuilzer, designed to operate continuously with tidal breathing
Roxon Medi-Tech, Montreal, PQ, Canada
Trudell AeroEclipse*II BAN nebulizer
The Trudell AeroEclipse\*II BAN nebulizer will be used to perform a methacholine challenge
Methacholine Chloride
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 nebulizer
Generates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methacholine Chloride
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 nebulizer
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 nebulizer
Continuous-mode nebuilzer, designed to operate continuously with tidal breathing
Roxon Medi-Tech, Montreal, PQ, Canada
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
* Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).
* Smokers
* Pregnant women.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McMaster University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gail Gauvreau
Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gail Gauvreau, PhD
Role: PRINCIPAL_INVESTIGATOR
Study investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIREB 11-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.