Asthma Clinical Trial
— PIFECOOfficial title:
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
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
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). |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Finland | Jorvi hospital | Helsinki | |
Finland | Skin and Allergy hospital | Helsinki | |
United Kingdom | Northern General Hospital | Sheffield | |
United Kingdom | Sheffield Children's Hospital | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Orion Corporation, Orion Pharma |
Finland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers | 1 Day | No | |
Secondary | Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate. | 1 Day | No | |
Secondary | Handling of the devices in the subpopulation of asthmatic children | 1 Day | No | |
Secondary | Acceptability of the inhalers in the subpopulation of asthmatic children | 1 Day | No |
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