Status:
COMPLETED
Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer
Lead Sponsor:
McMaster University
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will compare the methacholine PC20 of two different modern-delivery aerosol systems to determine if one may replace the other for use in clinical settings.
Detailed Description
Thirty three asthmatic subjects (\>18 years, both sexes) who have stable asthma will be recruited to undergo methacholine challenges for a randomized, crossover, observational study. The objective of ...
Eligibility Criteria
Inclusion
- Subjects with stable asthma.
- Tidal breathing PC20≤16 mg/mL.
- Baseline FEV1 more than 65% of predicted normal.
- Able to complete 3 methacholine challenges on 3 separate days at the same time of day, at least 24-hours apart and within a 2-week period. (1 during screening and the other 2 during the study)
Exclusion
- Airway infection or allergen exposure during the last 4 weeks.
- Exacerbation during the last 4 weeks.
- Change in dosage of inhaled or oral steroids during the last 4 weeks.
- Inhaled salbutamol less than 8 hours prior to testing.
- Inhaled formoterol or salmeterol less than 36 hours prior to testing.
- Antihistamines during the last 48 hours.
- Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).
- Smokers
- Pregnant women.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01919424
Start Date
April 1 2011
End Date
October 1 2013
Last Update
April 15 2015
Active Locations (1)
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1
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, Canada, L8N 3Z5