AsthmaPhase 1/2KINECONCT00964535
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
A Phase 1/2 study testing budesonide and formoterol 200/6 microg in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide and formoterol 200/6 microg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Males or females aged 18-60 years with documented diagnosis of asthma
- Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
- The asthma should be stable on the same regular treatment for at least 4 weeks before screening.
Who cannot join
- Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
- Respiratory infection within 4 weeks preceding the screening
- Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
- Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
- Conditions
- Asthma
- Being tested
- budesonide and formoterol 200/6 microg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide and formoterol 200/6 microgDrug
Also called Budesonide/formoterol Easyhaler 200/6 microg/inhalation
2 inhalations as a single dose
budesonide and formoterol 200/6 microgDrug
Also called Symbicort Turbohaler 200/6 microg/inhalation
2 inhalations as a single dose
budesonide and formoterol 200/6 microgDrug
Also called Budesonide/formoterol Easyhaler 200/6 microg/inhalation
2 inhalations as a single dose with the concurrent charcoal blockage
budesonide and formoterol 200/6 microgDrug
Also called Symbicort Turbohaler 200/6 microg/inhalation
2 inhalations as a single dose with the concurrent charcoal blockage
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/formoterol Easyhaler | Experimental | Not described Receives: Drug: budesonide and formoterol 200/6 microg |
| Charcoal and Budesonide/formoterol EH | Experimental | Not described Receives: Drug: budesonide and formoterol 200/6 microg |
| Symbicort Turbohaler | Active comparator | Not described Receives: Drug: budesonide and formoterol 200/6 microg |
| Charcoal and Symbicort Turbohaler | Active comparator | Not described Receives: Drug: budesonide and formoterol 200/6 microg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
Measured: within 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ulla Sairanen, MSc, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964535
- Sponsor's protocol ID
- 3103002
- Acronym
- KINECO
- Status last verified
- Feb 2010
- First submitted
- 24 Aug 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation
- ClinicalTrials.gov ID
- NCT00964535
- Acronym / sponsor ID
- KINECO / 3103002
- Conditions
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Aug 2009 (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 Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide/formoterol Easyhaler | Experimental | Drug: budesonide and formoterol 200/6 microg |
| Charcoal and Budesonide/formoterol EH | Experimental | Drug: budesonide and formoterol 200/6 microg |
| Symbicort Turbohaler | Active comparator | Drug: budesonide and formoterol 200/6 microg |
| Charcoal and Symbicort Turbohaler | Active comparator | Drug: budesonide and formoterol 200/6 microg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females aged 18-60 years with documented diagnosis of asthma
- Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
- The asthma should be stable on the same regular treatment for at least 4 weeks before screening.
Key exclusion criteria (4 listed)
- Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
- Respiratory infection within 4 weeks preceding the screening
- Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
- Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for 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 |
|---|---|---|
| budesonide and formoterol 200/6 microgAlso: Budesonide/formoterol Easyhaler 200/6 microg/inhalation2 inhalations as a single dose | Drug | Budesonide/formoterol Easyhaler |
| budesonide and formoterol 200/6 microgAlso: Symbicort Turbohaler 200/6 microg/inhalation2 inhalations as a single dose | Drug | Symbicort Turbohaler |
| budesonide and formoterol 200/6 microgAlso: Budesonide/formoterol Easyhaler 200/6 microg/inhalation2 inhalations as a single dose with the concurrent charcoal blockage | Drug | Charcoal and Budesonide/formoterol EH |
| budesonide and formoterol 200/6 microgAlso: Symbicort Turbohaler 200/6 microg/inhalation2 inhalations as a single dose with the concurrent charcoal blockage | Drug | Charcoal and Symbicort Turbohaler |
Primary outcome
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
Time frame: within 24 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 15 Feb 2010.
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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, MSc 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 1/2 study testing budesonide and formoterol 200/6 microg in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
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 15 Feb 2010. 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 United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 parameters Cmax and AUCt of plasma budesonide and formoterol concentrations (time frame: within 24 h). 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 15 Feb 2010.