Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

Not Applicable

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease
• Interventions: Device: Diskus inhaler; Device: Easyhaler type A; Device: Easyhaler type B

• Registration Number: NCT01424137
• Lead Sponsor: Orion Corporation, Orion Pharma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• Written informed consent (IC) obtained
• Documented diagnosis of asthma and/or COPD
• Age: 4 years and above

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diskus inhaler	Diskus inhaler	-
Easyhaler type A	Easyhaler type A	-
Easyhaler type B	Easyhaler type B	-

Primary Outcome Measures

Name	Time	Method
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers	1 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Tartu University Hospital, Lung Clinic; 🇪🇪 Tartu, Estonia

Turku University Hospital; 🇫🇮 Turku, Finland

Children's Clinic of Tartu, Allergy Centre; 🇪🇪 Tartu, Estonia

Jorvi Hospital HUS; 🇫🇮 Espoo, Finland

Lasnamäe Medicum; 🇪🇪 Tallinn, Estonia