Asthma, Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).
Interventions
DEVICEEasyhaler type A
Easyhaler type A inhaler, 3 consecutive inhalations
DEVICEEasyhaler type B
Easyhaler type B inhaler, 3 consecutive inhalations
DEVICEDiskus inhaler
Diskus inhaler, 3 consecutive inhalations
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent (IC) obtained * Documented diagnosis of asthma and/or COPD * Age: 4 years and above
Exclusion criteria
* Any severe chronic respiratory disease other than asthma or COPD * Acute respiratory infection * Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate | 1 day |
Countries
Estonia, Finland
Outcome results
None listed