AeroEclipse II Agreement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharon Dell, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01288482
First received: January 28, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Device: AeroEclipse II breath-actuated nebulizer
Device: English-Wright continuous-mode nebulizer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Methacholine inhalation challenge [ Time Frame: Visit 1(Day 1) ] [ Designated as safety issue: No ]
    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)

  • Methacholine inhalation challenge [ Time Frame: Visit 2 (up to 2 weeks) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Methacholine challenge - Cumulative Effect [ Time Frame: Week 3 +/- 1 week ] [ Designated as safety issue: No ]
    There exists the possibility that as a result of decreased nebulisation time, we may see some cumulative effect from shortening the time between doubling doses of methacholine. If there is a systematic difference between the English-Wright and the AeroEclipse II nebulizers, it will then be impossible to know if we have calculated the wrong dose or we are seeing a cumulative effect. Therefore we are proposing that the first 10 patients participate in a third visit to look for a cumulative effect.


Enrollment: 32
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthma Subjects Device: AeroEclipse II breath-actuated nebulizer
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.
Device: English-Wright continuous-mode nebulizer
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.

Detailed Description:

This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20% decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 10 to 65 years at time of recruitment into this study,
  2. Diagnosis of current asthma by a health care professional,
  3. Tidal breathing Provocation Concentration ≤ 16 mg/mL,
  4. Forced Expiratory Volume 1> 65% of predicted,
  5. No respiratory tract infection or allergen exposure ≥ 4 weeks,
  6. 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,
  7. Inhaled salbutamol withheld for ≥8 hours prior to testing,
  8. Inhaled corticosteroid maintained at same dose throughout study,
  9. inhaled formoterol and salmeterol withheld for ≥36 hours prior to testing.

Exclusion Criteria:

  1. Those born prematurely (more than 4 weeks early of the calculated date),
  2. Those with chronic health conditions like diabetes or cystic fibrosis,
  3. Smokers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288482

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Sharon Dell, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Sharon Dell, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01288482     History of Changes
Other Study ID Numbers: 1000019446
Study First Received: January 28, 2011
Last Updated: May 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Methacholine challenge
nebulizer
English-Wright
AeroEclipse II

ClinicalTrials.gov processed this record on October 23, 2014