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Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00984906
Acronym
PIFECO
Enrollment
200
Registered
2009-09-25
Start date
2009-09-30
Completion date
2010-03-31
Last updated
2010-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Pulmonary Disease, Chronic Obstructive

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.

Interventions

OTHEREmpty inhalers

Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler

Sponsors

Orion Corporation, Orion Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frame
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers1 Day

Secondary

MeasureTime 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 children1 Day
Acceptability of the inhalers in the subpopulation of asthmatic children1 Day

Countries

Finland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026