Clinical trial NCT01288482: AeroEclipse II Agreement
Official title: Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Methacholine challenge
nebulizer
English-Wright
AeroEclipse II
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Methacholine inhalation challenge
timeFrame: Visit 1(Day 1)
measure: Methacholine inhalation challenge
timeFrame: Visit 2 (up to 2 weeks)
Secondary outcomes:
measure: Methacholine challenge - Cumulative Effect
timeFrame: Week 3 +/- 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Sharon Dell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.