AsthmaSALIFNCT01424137
Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)
A study testing Easyhaler type A, Easyhaler type B and Diskus inhaler in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Orion Corporation, Orion Pharma at 5 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Easyhaler type A, Easyhaler type B and Diskus inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent (IC) obtained
- Documented diagnosis of asthma and/or COPD
- Age: 4 years and above
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Estonia3 sites
Lasnamäe Medicum
Tallinn, 13619
Children's Clinic of Tartu, Allergy Centre
Tartu, 51014
Tartu University Hospital, Lung Clinic
Tartu, 51014
Finland2 sites
Jorvi Hospital HUS
Espoo, 02740
Turku University Hospital
Turku, 20520
About this study
Official title: Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
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).
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Easyhaler type A, Easyhaler type B, Diskus inhaler
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easyhaler type ADevice
Also called SF EH (D94-2SF)
Easyhaler type A inhaler, 3 consecutive inhalations
Easyhaler type BDevice
Also called SF EH (D94-2SF-B)
Easyhaler type B inhaler, 3 consecutive inhalations
Diskus inhalerDevice
Also called Inhaler for Seretide Diskus
Diskus inhaler, 3 consecutive inhalations
| Study group | Role | What they receive |
|---|---|---|
| Easyhaler type A | Other | Not described Receives: Device: Easyhaler type A |
| Easyhaler type B | Other | Not described Receives: Device: Easyhaler type B |
| Diskus inhaler | Other | Not described Receives: Device: Diskus inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kati Kaijasilta, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424137
- Sponsor's protocol ID
- 3106002
- Acronym
- SALIF
- Status last verified
- Feb 2012
- First submitted
- 24 Aug 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38170393
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
- ClinicalTrials.gov ID
- NCT01424137
- Acronym / sponsor ID
- SALIF / 3106002
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Easyhaler type A | Other | Device: Easyhaler type A |
| Easyhaler type B | Other | Device: Easyhaler type B |
| Diskus inhaler | Other | Device: Diskus inhaler |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent (IC) obtained
- Documented diagnosis of asthma and/or COPD
- Age: 4 years and above
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Easyhaler type AAlso: SF EH (D94-2SF)Easyhaler type A inhaler, 3 consecutive inhalations | Device | Easyhaler type A |
| Easyhaler type BAlso: SF EH (D94-2SF-B)Easyhaler type B inhaler, 3 consecutive inhalations | Device | Easyhaler type B |
| Diskus inhalerAlso: Inhaler for Seretide DiskusDiskus inhaler, 3 consecutive inhalations | Device | Diskus inhaler |
Primary outcome
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
Time frame: 1 day
1 secondary outcome
The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Derived from this study: PubMed 38170393Kainu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kati Kaijasilta study director
Orion Corporation, Orion Pharma
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Easyhaler type A, Easyhaler type B and Diskus inhaler in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Orion Corporation, Orion Pharma at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Estonia, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.