NCT00984906CompletedNot Applicable
Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD
Orion Corporation, Orion Pharma4 sites in 2 countries200 target enrollmentStarted: September 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Study Overview
Brief Summary
The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent obtained.
- •Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
- •Age: 6 years or above.
Exclusion Criteria
- •Any severe chronic respiratory disease other than asthma or COPD.
- •Acute respiratory infection.
- •Concurrent participation in a clinical drug study.
- •Inability to perform repeatable spirometric measurements.
- •Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).
Outcomes
Primary Outcomes
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Time Frame: 1 Day
Secondary Outcomes
- Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.(1 Day)
- Acceptability of the inhalers in the subpopulation of asthmatic children(1 Day)
- Handling of the devices in the subpopulation of asthmatic children(1 Day)
Investigators
Study Sites (4)
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