Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer

NCT01919424 | Completed

• 1 other identifier: HIREB 11-004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (2)

'The English-Wright nebulizer'

ACTIVE COMPARATOR

The English-Wright nebulizer will be used to perform a methacholine challenge.

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

Drug: Methacholine Chloride; Device: Trudell AeroEclipse*II BAN nebulizer

Interventions

Methacholine Chloride DRUG

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'; Trudell AeroEclipse*II BAN nebulizer

Trudell AeroEclipse*II BAN nebulizer DEVICE

Generates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value

Trudell AeroEclipse*II BAN nebulizer

The English-Wright nebulizer DEVICE

Continuous-mode nebuilzer, designed to operate continuously with tidal breathing Roxon Medi-Tech, Montreal, PQ, Canada

'The English-Wright nebulizer'

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).
• Smokers
• Pregnant women.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 25871542 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Gail Gauvreau, PhD

  Study investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 9, 2013
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

CA (1)