Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler 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.

Official 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

Conditions
-----------------
Asthma, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Empty inhalers


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Empty Easyhaler type A<br> | Other: Empty inhalers<br>* Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler<br>* Other names: Empty device-metered dry powder inhaler Turbohaler;|
| Other: Empty Easyhaler type B<br> | Other: Empty inhalers<br>* Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler<br>* Other names: Empty device-metered dry powder inhaler Turbohaler;|
| Other: Empty Turbohaler<br> | Other: Empty inhalers<br>* Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler<br>* Other names: Empty device-metered dry powder inhaler Turbohaler;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate. |  | 1 Day | 
| Handling of the devices in the subpopulation of asthmatic children |  | 1 Day | 
| Acceptability of the inhalers in the subpopulation of asthmatic children |  | 1 Day |