AsthmaPhase 1NCT02162485
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
A Phase 1 study testing Salmeterol/fluticasone Easyhaler, Salmeterol/fluticasone Easyhaler with charcoal and Seretide Diskus in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream 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?
- Salmeterol/fluticasone Easyhaler, Salmeterol/fluticasone Easyhaler with charcoal and Seretide Diskus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2014to Sep 2015
- 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
- Written informed consent obtained
- Good general health ascertained by detailed medical history, and laboratory and physical examinations
Who cannot join
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
- Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
- Conditions
- Asthma
- Being tested
- Salmeterol/fluticasone Easyhaler, Salmeterol/fluticasone Easyhaler with charcoal, Seretide Diskus, Seretide Diskus with charcoal
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/fluticasone EasyhalerDrug
Salmeterol/fluticasone Easyhaler with charcoalDrug
Seretide DiskusDrug
Seretide Diskus with charcoalDrug
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol/fluticasone Easyhaler | Experimental | Single dose of Salmeterol/fluticasone Easyhaler Receives: Drug: Salmeterol/fluticasone Easyhaler |
| Salmeterol/fluticasone Easyhaler with charcoal | Experimental | Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules) Receives: Drug: Salmeterol/fluticasone Easyhaler with charcoal |
| Seretide Diskus | Active comparator | Single dose of Seretide Diskus Receives: Drug: Seretide Diskus |
| Seretide Diskus with charcoal | Active comparator | Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules) Receives: Drug: Seretide Diskus with charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of plasma salmeterol and fluticasone propionate
Measured: within 34 h
AUCt of plasma salmeterol and fluticasone propionate
Measured: 34 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merja Mäkitalo, Study director, Orion Corporation, Orion PharmaLeena Mattila, MD, PhD, Principal investigator, Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162485
- Sponsor's protocol ID
- 3106009
- Status last verified
- Sep 2015
- First submitted
- 5 Jun 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02162485
- Acronym / sponsor ID
- 3106009
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Jun 2014 (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 purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salmeterol/fluticasone Easyhaler | Experimental | Drug: Salmeterol/fluticasone EasyhalerSingle dose of Salmeterol/fluticasone Easyhaler |
| Salmeterol/fluticasone Easyhaler with charcoal | Experimental | Drug: Salmeterol/fluticasone Easyhaler with charcoalSingle dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules) |
| Seretide Diskus | Active comparator | Drug: Seretide DiskusSingle dose of Seretide Diskus |
| Seretide Diskus with charcoal | Active comparator | Drug: Seretide Diskus with charcoalSingle dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Written informed consent obtained
- Good general health ascertained by detailed medical history, and laboratory and physical examinations
Key exclusion criteria (4 listed)
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed
- Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) 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 |
|---|---|---|
| Salmeterol/fluticasone Easyhaler | Drug | Salmeterol/fluticasone Easyhaler |
| Salmeterol/fluticasone Easyhaler with charcoal | Drug | Salmeterol/fluticasone Easyhaler with charcoal |
| Seretide Diskus | Drug | Seretide Diskus |
| Seretide Diskus with charcoal | Drug | Seretide Diskus with charcoal |
Primary outcome
Cmax of plasma salmeterol and fluticasone propionate
Time frame: within 34 h
AUCt of plasma salmeterol and fluticasone propionate
Time frame: 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 29 Sep 2015.
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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.
Merja Mäkitalo study director
Orion Corporation, Orion Pharma
Leena Mattila, MD, PhD principal investigator
Orion Pharma Clinical Pharmacology Unit, Espoo, Finland
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 Salmeterol/fluticasone Easyhaler, Salmeterol/fluticasone Easyhaler with charcoal and Seretide Diskus 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 4 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 29 Sep 2015. 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?
Cmax of plasma salmeterol and fluticasone propionate (time frame: within 34 h). The study lists 2 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 29 Sep 2015.