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 enrollmentSeptember 2009

ConditionsAsthma Pulmonary Disease, Chronic Obstructive

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 200
Locations: 4
Primary Endpoint: Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Orion Corporation, Orion Pharma

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).

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)