AsthmaPhase 1NCT03073057
Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
A Phase 1 study testing Budesonide/formoterol, Charcoal and Symbicort Turbuhaler 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 Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into 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?
- Budesonide/formoterol, Charcoal and Symbicort Turbuhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2016to Mar 2016
- 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
- Body mass index > 19 and < 30kg/m2, weight at least 50 kg
- 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
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
- Known hypersensitivity to the active substance(s) or the excipient of the drug
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol, Charcoal, Symbicort Turbuhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterolDrug
Also called Budesonide/formoterol 160/4.5microg
2 inhalations as a single dose
CharcoalOther
Symbicort TurbuhalerDrug
Also called Symbicort Turbuhaler 160/4.5 microg
2 inhalations as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler A | Experimental | 160/4.5microg/inhalation Charcoal Receives: Drug: Budesonide/formoterol; Other: Charcoal |
| Charcoal and Budesonide/formoterol Easyhaler B | Experimental | 160/4.5microg/inhalation Charcoal Receives: Drug: Budesonide/formoterol; Other: Charcoal |
| Charcoal and Budesonide/formoterol Easyhaler C | Experimental | 160/4.5microg/inhalation Charcoal Receives: Drug: Budesonide/formoterol; Other: Charcoal |
| Charcoal and Symbicort Turbuhaler | Active comparator | 160/4.5microg/inhalation Charcoal Receives: Other: Charcoal; Drug: Symbicort Turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of plasma budesonide and formoterol
Measured: within 24 hours
AUCt of plasma budesonide and formoterol
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iissa Kivisto, Study director, Orion Corporation, Orion PharmaLeena Mattila, MD, Principal investigator, Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073057
- Sponsor's protocol ID
- 3103014
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03073057
- Acronym / sponsor ID
- 3103014
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Mar 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 Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler A | Experimental | Drug: Budesonide/formoterol, Other: Charcoal160/4.5microg/inhalation Charcoal |
| Charcoal and Budesonide/formoterol Easyhaler B | Experimental | Drug: Budesonide/formoterol, Other: Charcoal160/4.5microg/inhalation Charcoal |
| Charcoal and Budesonide/formoterol Easyhaler C | Experimental | Drug: Budesonide/formoterol, Other: Charcoal160/4.5microg/inhalation Charcoal |
| Charcoal and Symbicort Turbuhaler | Active comparator | Other: Charcoal, Drug: Symbicort Turbuhaler160/4.5microg/inhalation Charcoal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent obtained
- Body mass index > 19 and < 30kg/m2, weight at least 50 kg
- 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
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
- Known hypersensitivity to the active substance(s) or the excipient of the drug
- Pregnant and 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 |
|---|---|---|
| Budesonide/formoterolAlso: Budesonide/formoterol 160/4.5microg2 inhalations as a single dose | Drug | Charcoal and Budesonide/formoterol Easyhaler A, Charcoal and Budesonide/formoterol Easyhaler B, Charcoal and Budesonide/formoterol Easyhaler C |
| Charcoal | Other | Charcoal and Budesonide/formoterol Easyhaler A, Charcoal and Budesonide/formoterol Easyhaler B, Charcoal and Budesonide/formoterol Easyhaler C, Charcoal and Symbicort Turbuhaler |
| Symbicort TurbuhalerAlso: Symbicort Turbuhaler 160/4.5 microg2 inhalations as a single dose | Drug | Charcoal and Symbicort Turbuhaler |
Primary outcome
Cmax of plasma budesonide and formoterol
Time frame: within 24 hours
AUCt of plasma budesonide and formoterol
Time frame: within 24 hours
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 8 Mar 2017.
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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.
Iissa Kivisto study director
Orion Corporation, Orion Pharma
Leena Mattila, MD 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 Budesonide/formoterol, Charcoal and Symbicort Turbuhaler 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 3 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 8 Mar 2017. 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 budesonide and formoterol (time frame: within 24 hours). 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 8 Mar 2017.