AsthmaPhase 1NCT03238482
Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
A Phase 1 study testing salmeterol-fluticasone 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 absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFinland
- Study dates
- 16 Aug 2017to 19 Dec 2017
- 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
Main inclusion Criteria:
- Written informed consent (IC) obtained.
- Males and females, 18-60 (inclusive) years of age.
- Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).
- Weight at least 50 kg.
Main exclusion Criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
- Any condition requiring regular concomitant treatment.
- Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Known hypersensitivity to the active substance(s) or the lactose.
- Pregnant or lactating females and females of childbearing potential not using proper contraception.
- Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
- Administration of another investigational medicinal product within 90 days prior to first study treatment administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects
The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
- Conditions
- Asthma
- Being tested
- salmeterol-fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salmeterol-fluticasoneDrug
Seretide Diskus 50/250 µg/dose
salmeterol-fluticasoneDrug
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
salmeterol-fluticasoneDrug
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
salmeterol-fluticasoneDrug
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
| Study group | Role | What they receive |
|---|---|---|
| Seretide Diskus | Active comparator | salmeterol-fluticasone 2 inhalations as a single dose Receives: Drug: salmeterol-fluticasone |
| Salmeterol/fluticasone Easyhaler, E | Experimental | salmeterol-fluticasone 2 inhalations as a single dose Receives: Drug: salmeterol-fluticasone |
| Salmeterol/fluticasone Easyhaler, F | Experimental | salmeterol-fluticasone 2 inhalations as a single dose Receives: Drug: salmeterol-fluticasone |
| Salmeterol/fluticasone Easyhaler, G | Experimental | salmeterol-fluticasone 2 inhalations as a single dose Receives: Drug: salmeterol-fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of salmeterol
Cmax of salmeterol
Measured: between 0-34 hours after dosing
Peak plasma concentration (Cmax) of fluticasone propionate
Cmax of fluticasone propionate
Measured: between 0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to the last sample with the quantifiable concentration
Measured: 0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
AUC from time zero to the last sample with the quantifiable concentration
Measured: 0-34 hours after dosing
Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to 30 min after study treatment administration
Measured: 0-30 minutes after dosing
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to infinity
Measured: 0-34 hours after dosing and extrapolation
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
AUC from time zero to infinity
Measured: 0-34 hours after dosing and extrapolation
The time to reach the maximum concentration (tmax) of salmeterol
tmax of salmeterol
Measured: 0-34 hours after dosing
The time to reach the maximum concentration (tmax) of fluticasone propionate
tmax of fluticasone propionate
Measured: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of salmeterol
t1/2 of salmeterol
Measured: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of fluticasone propionate
t1/2 of fluticasone propionate
Measured: 0-34 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start16 Aug 2017
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulla Sairanen, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238482
- Sponsor's protocol ID
- 3106012
- Status last verified
- Apr 2018
- First submitted
- 11 Jul 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03238482
- Acronym / sponsor ID
- 3106012
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 3 Aug 2017 (actual)
- 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 absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Seretide Diskus | Active comparator | Drug: salmeterol-fluticasonesalmeterol-fluticasone 2 inhalations as a single dose |
| Salmeterol/fluticasone Easyhaler, E | Experimental | Drug: salmeterol-fluticasonesalmeterol-fluticasone 2 inhalations as a single dose |
| Salmeterol/fluticasone Easyhaler, F | Experimental | Drug: salmeterol-fluticasonesalmeterol-fluticasone 2 inhalations as a single dose |
| Salmeterol/fluticasone Easyhaler, G | Experimental | Drug: salmeterol-fluticasonesalmeterol-fluticasone 2 inhalations as a single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-fluticasoneSeretide Diskus 50/250 µg/dose | Drug | Seretide Diskus |
| salmeterol-fluticasoneSalmeterol/fluticasone Easyhaler 50/250 µg/dose, product E | Drug | Salmeterol/fluticasone Easyhaler, E |
| salmeterol-fluticasoneSalmeterol/fluticasone Easyhaler 50/250 µg/dose, product F | Drug | Salmeterol/fluticasone Easyhaler, F |
| salmeterol-fluticasoneSalmeterol/fluticasone Easyhaler 50/250 µg/dose, product G | Drug | Salmeterol/fluticasone Easyhaler, G |
Primary outcome
Peak plasma concentration (Cmax) of salmeterol
Time frame: between 0-34 hours after dosing
Cmax of salmeterol
Peak plasma concentration (Cmax) of fluticasone propionate
Time frame: between 0-34 hours after dosing
Cmax of fluticasone propionate
Area under the plasma concentration versus time curve (AUC) of salmeterol
Time frame: 0-34 hours after dosing
AUC from time zero to the last sample with the quantifiable concentration
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Time frame: 0-34 hours after dosing
AUC from time zero to the last sample with the quantifiable concentration
Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
Time frame: 0-30 minutes after dosing
AUC from time zero to 30 min after study treatment administration
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of salmeterol
Time frame: 0-34 hours after dosing and extrapolation
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Time frame: 0-34 hours after dosing and extrapolation
The time to reach the maximum concentration (tmax) of salmeterol
Time frame: 0-34 hours after dosing
The time to reach the maximum concentration (tmax) of fluticasone propionate
Time frame: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of salmeterol
Time frame: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of fluticasone propionate
Time frame: 0-34 hours after dosing
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 6 Apr 2018.
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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.
Ulla Sairanen study director
Orion Corporation, Orion Pharma
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 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?
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 6 Apr 2018. 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?
Peak plasma concentration (Cmax) of salmeterol (time frame: between 0-34 hours after dosing). The study lists 5 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 6 Apr 2018.