Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers

Not Applicable

Completed

• Conditions: Asthma; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Empty inhalers

• Registration Number: NCT00984906
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-07
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Empty Easyhaler type A	Empty inhalers	-
Empty Easyhaler type B	Empty inhalers	-
Empty Turbohaler	Empty inhalers	-

Primary Outcome Measures

Name	Time	Method
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers	1 Day

Secondary Outcome Measures

Name	Time	Method
Acceptability of the inhalers in the subpopulation of asthmatic children	1 Day
Handling of the devices in the subpopulation of asthmatic children	1 Day
Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.	1 Day

Trial Locations

Locations (4)

Skin and Allergy hospital; 🇫🇮 Helsinki, Finland

Jorvi hospital; 🇫🇮 Helsinki, Finland

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Sheffield Children's Hospital; 🇬🇧 Sheffield, United Kingdom