Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

Asthma Clinical Trial

— SALIF  

Official title:

Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424137
• Other study ID #: 3106002
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: February 2, 2012
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent (IC) obtained

• Documented diagnosis of asthma and/or COPD

• Age: 4 years and above

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Easyhaler type A
Easyhaler type A inhaler, 3 consecutive inhalations
• Easyhaler type B
Easyhaler type B inhaler, 3 consecutive inhalations
• Diskus inhaler
Diskus inhaler, 3 consecutive inhalations

Locations

Country	Name	City	State
Estonia	Lasnamäe Medicum	Tallinn
Estonia	Children's Clinic of Tartu, Allergy Centre	Tartu
Estonia	Tartu University Hospital, Lung Clinic	Tartu
Finland	Jorvi Hospital HUS	Espoo
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Estonia,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers		1 day	No
Secondary	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	No