AsthmaPhase 1NCT01386996
Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
A Phase 1 study testing Budesonide/formoterol Easyhaler 320/9 microg and Symbicort Turbuhaler forte 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 Budesonide/formoterol Easyhaler 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 Easyhaler 320/9 microg and Symbicort Turbuhaler forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2011to Nov 2011
- 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 a 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: Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol Easyhaler 320/9 microg, Symbicort Turbuhaler forte
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterol Easyhaler 320/9 microgDrug
2 inhalations as a single dose
Symbicort Turbuhaler forteDrug
2 inhalations as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol Easyhaler 320/9 microg |
| Charcoal and Symbicort Turbuhaler | Active comparator | Not described Receives: Drug: Symbicort Turbuhaler forte |
| Budesonide/formoterol Easyhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol Easyhaler 320/9 microg |
| Symbicort Turbuhaler | Active comparator | Not described Receives: Drug: Symbicort Turbuhaler forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter Cmax of plasma budesonide concentration
Measured: within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
Measured: 12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
Measured: 24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulla Sairanen, MSc, Study director, Orion Corporation, Orion PharmaKimmo Ingman, MD, PhD, Principal investigator, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386996
- Sponsor's protocol ID
- 3103004
- Status last verified
- Dec 2011
- First submitted
- 23 Jun 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01386996
- Acronym / sponsor ID
- 3103004
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Jul 2011 (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 Turbuhaler 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 |
|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler | Experimental | Drug: Budesonide/formoterol Easyhaler 320/9 microg |
| Charcoal and Symbicort Turbuhaler | Active comparator | Drug: Symbicort Turbuhaler forte |
| Budesonide/formoterol Easyhaler | Experimental | Drug: Budesonide/formoterol Easyhaler 320/9 microg |
| Symbicort Turbuhaler | Active comparator | Drug: Symbicort Turbuhaler forte |
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 a 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 |
|---|---|---|
| Budesonide/formoterol Easyhaler 320/9 microg2 inhalations as a single dose | Drug | Budesonide/formoterol Easyhaler, Charcoal and Budesonide/formoterol Easyhaler |
| Symbicort Turbuhaler forte2 inhalations as a single dose | Drug | Charcoal and Symbicort Turbuhaler, Symbicort Turbuhaler |
Primary outcome
Pharmacokinetic parameter Cmax of plasma budesonide concentration
Time frame: within 12 h
Pharmacokinetic parameter AUCt of plasma budesonide concentration
Time frame: 12 h
Pharmacokinetic parameter Cmax of plasma formoterol concentration
Time frame: 24 h
Pharmacokinetic parameter AUCt of plasma formoterol concentration
Time frame: 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 22 Dec 2011.
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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
Kimmo Ingman, MD, PhD principal investigator
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 Budesonide/formoterol Easyhaler 320/9 microg and Symbicort Turbuhaler forte 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 22 Dec 2011. 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 budesonide concentration (time frame: within 12 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 22 Dec 2011.