AeroEclipse II Agreement

NCT01288482 | Completed Phase 4

• 1 other identifier: 1000019446
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any fellow-patients, family members, or health-care workers in the vicinity. The English-Wright has been the only American Thoracic Society (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further validate their performance. The investigators expect to show equivalence between the AeroEclipse II and the English-Wright nebulizers.

Conditions

Asthma

Keywords

Methacholine challenge; nebulizer; English-Wright; AeroEclipse II

Outcome Measures

Primary Outcomes (2)

• Methacholine inhalation challenge

  A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)

  Visit 1(Day 1)

• Methacholine inhalation challenge

  A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)

  Visit 2 (up to 2 weeks)

Secondary Outcomes (1)

• Methacholine challenge - Cumulative Effect

  Week 3 +/- 1 week

Study Arms (1)

Asthma Subjects

EXPERIMENTAL

Device: AeroEclipse II breath-actuated nebulizer; Device: English-Wright continuous-mode nebulizer

Interventions

AeroEclipse II breath-actuated nebulizer DEVICE

The AeroEclipse II (Trudell Medicinal International, London, ON, Canada) is a breath-actuated nebulizer that allows for the creation of aerosol only in response to the patient's inspiratory flow, resulting in virtually no drug loss to the environment and providing a safer healthcare and patient environment by significantly reducing second-hand drug exposure and the possibility for transmission of viral airborne pathogens.

Asthma Subjects

English-Wright continuous-mode nebulizer DEVICE

The English-Wright is a continuous-mode nebulizer, designed to operate continuously with tidal breathing, producing an aerosol which is lost to the environment possibly posing a hazard to any fellow-patients, family members, or health-care workers in the vicinity. It is the only device recommended by the American Thoracic Society guidelines that is available on the market and it has recently been discontinued. For these reasons it is necessary to review the use of other nebulizers and validate their performance.

Asthma Subjects

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 10 to 65 years at time of recruitment into this study,
• Diagnosis of current asthma by a health care professional,
• Tidal breathing Provocation Concentration ≤ 16 mg/mL,
• Forced Expiratory Volume 1\> 65% of predicted,
• No respiratory tract infection or allergen exposure ≥ 4 weeks,
• Able to complete 2 methacholine inhalation challenges on 2 separate days at the same time of day, at least 24-h apart, and within a 2-week period,
• Inhaled salbutamol withheld for ≥8 hours prior to testing,
• Inhaled corticosteroid maintained at same dose throughout study,
• inhaled formoterol and salmeterol withheld for ≥36 hours prior to testing.

You may not qualify if:

• Those born prematurely (more than 4 weeks early of the calculated date),
• Those with chronic health conditions like diabetes or cystic fibrosis,
• Smokers.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Dell SD, Bola SS, Foty RG, Marshall LC, Nelligan KA, Coates AL. Provocative dose of methacholine causing a 20% drop in FEV1 should be used to interpret methacholine challenge tests with modern nebulizers. Ann Am Thorac Soc. 2015 Mar;12(3):357-63. doi: 10.1513/AnnalsATS.201409-433OC.

  PMID: 25575246 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Sharon Dell, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 2, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)