Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)
SALIF
Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
1 other identifier
interventional
227
2 countries
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Sep 2011
Shorter than P25 for not_applicable asthma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 3, 2012
February 1, 2012
2 months
August 24, 2011
February 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
1 day
Secondary Outcomes (1)
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
Study Arms (3)
Easyhaler type A
OTHEREasyhaler type B
OTHERDiskus inhaler
OTHERInterventions
Easyhaler type A inhaler, 3 consecutive inhalations
Easyhaler type B inhaler, 3 consecutive inhalations
Diskus inhaler, 3 consecutive inhalations
Eligibility Criteria
You may qualify if:
- Written informed consent (IC) obtained
- Documented diagnosis of asthma and/or COPD
- Age: 4 years and above
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Lasnamäe Medicum
Tallinn, 13619, Estonia
Children's Clinic of Tartu, Allergy Centre
Tartu, 51014, Estonia
Tartu University Hospital, Lung Clinic
Tartu, 51014, Estonia
Jorvi Hospital HUS
Espoo, 02740, Finland
Turku University Hospital
Turku, 20520, Finland
Related Publications (1)
Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.
PMID: 38170393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kati Kaijasilta
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 3, 2012
Record last verified: 2012-02