AeroEclipse II Agreement

The Hospital for Sick Children

Status and phase: Completed; Phase 4

Conditions: Asthma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01288482

1000019446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Asthma Subjects

Experimental group

Treatment:

Device: English-Wright continuous-mode nebulizer

Device: AeroEclipse II breath-actuated nebulizer