AeroEclipse II Agreement

Asthma Clinical Trial

Official title:

Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288482
• Other study ID #: 1000019446
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2011
• Last updated: May 12, 2014
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Methacholine challenge - Cumulative Effect	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.	Week 3 +/- 1 week	No