AsthmaPhase 1NCT01766843
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
A Phase 1 study testing Seretide Diskus and charcoal, Seretide Diskus and SF Easyhaler and charcoal in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Seretide Diskus and charcoal, Seretide Diskus and SF Easyhaler and charcoal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to May 2013
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18-60 years
- Normal weight, at least 50 kg
Who cannot join
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Known hypersensitivity to the active substance(s) or the excipient of the drug.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
- Conditions
- Asthma
- Being tested
- Seretide Diskus and charcoal, Seretide Diskus, SF Easyhaler and charcoal, SF Easyhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seretide Diskus and charcoalDrug
2 inhalations as a single dose
Seretide DiskusDrug
2 inhalations as a single dose
SF Easyhaler and charcoalDrug
2 inhalations as a single dose
SF EasyhalerDrug
2 inhalations as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Seretide Diskus and charcoal | Active comparator | Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal Receives: Drug: Seretide Diskus and charcoal |
| Seretide Diskus | Active comparator | Single-dose of Seretide Diskus (50/500 mcg/inhalation) Receives: Drug: Seretide Diskus |
| SF Easyhaler and charcoal | Experimental | Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal Receives: Drug: SF Easyhaler and charcoal |
| SF Easyhaler | Experimental | Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) Receives: Drug: SF Easyhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Measured: Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
Measured: Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
Measured: within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Measured: within 34 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leena Mattila, MD, PhD, Principal investigator, Orion Corporation, Orion PharmaMaria Sokka, Study director, IRW Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766843
- Sponsor's protocol ID
- 3106007, EudraCT 2012-00378-41
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01766843
- Acronym / sponsor ID
- 3106007, EudraCT 2012-00378-41
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jan 2013 (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 compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Seretide Diskus and charcoal | Active comparator | Drug: Seretide Diskus and charcoalSingle-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal |
| Seretide Diskus | Active comparator | Drug: Seretide DiskusSingle-dose of Seretide Diskus (50/500 mcg/inhalation) |
| SF Easyhaler and charcoal | Experimental | Drug: SF Easyhaler and charcoalSalmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal |
| SF Easyhaler | Experimental | Drug: SF EasyhalerSalmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females aged 18-60 years
- Normal weight, at least 50 kg
Key exclusion criteria (5 listed)
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Known hypersensitivity to the active substance(s) or the excipient of the drug.
- Pregnant or lactating females.
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 |
|---|---|---|
| Seretide Diskus and charcoal2 inhalations as a single dose | Drug | Seretide Diskus and charcoal |
| Seretide Diskus2 inhalations as a single dose | Drug | Seretide Diskus |
| SF Easyhaler and charcoal2 inhalations as a single dose | Drug | SF Easyhaler and charcoal |
| SF Easyhaler2 inhalations as a single dose | Drug | SF Easyhaler |
Primary outcome
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Time frame: Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
Time frame: Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
Time frame: within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
Time frame: within 34 h
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 Jan 2014.
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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.
Leena Mattila, MD, PhD principal investigator
Orion Corporation, Orion Pharma
Maria Sokka study director
IRW Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seretide Diskus and charcoal, Seretide Diskus and SF Easyhaler and charcoal in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
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 2 inclusion and 5 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pharmacokinetic parameter Cmax of plasma salmeterol concentration (time frame: Within 34 h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2014.