HealthyNCT01457716
Pharmacokinetic Pilot Study on Budesonide/Formoterol
A study testing Budesonide, Formoterol and Easyhaler in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Budesonide, Formoterol and Easyhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Dec 2011
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females, 18-55 years of age.
- Normal weight at least 50 kg.
Who cannot join
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
- Any 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.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.
- Conditions
- Healthy
- Being tested
- Budesonide, Formoterol, Easyhaler, Turbohaler Forte
- Keywords
- Healthy volunteer study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Single inhalation
FormoterolDrug
Single inhalation
EasyhalerDevice
Inhaler device
Turbohaler ForteDevice
Inhaler device
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/Formoterol Easyhaler A | Experimental | Not described Receives: Drug: Budesonide; Drug: Formoterol; Device: Easyhaler |
| Budesonide/Formoterol Easyhaler B | Experimental | Not described Receives: Drug: Budesonide; Drug: Formoterol; Device: Easyhaler |
| Budesonide/Formoterol Easyhaler C | Experimental | Not described Receives: Drug: Budesonide; Drug: Formoterol; Device: Easyhaler |
| Budesonide/Formoterol Turbohaler Forte | Active comparator | Not described Receives: Drug: Budesonide; Drug: Formoterol; Device: Turbohaler Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Budesonide and Formoterol
Measured: 24 hours
AUCt of Budesonide and Formoterol
Measured: 24 hours
Secondary outcomes (3)
AUCinf of Budesonide and Formoterol
Measured: 24 hours
tmax of Budesonide and Formoterol
Measured: 24 hours
t1/2 of Budesonide and Formoterol
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johanna Hietamäki, MSc, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457716
- Sponsor's protocol ID
- 3103007
- Status last verified
- Feb 2012
- First submitted
- 28 Sep 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01457716
- Acronym / sponsor ID
- 3103007
- Conditions
- Healthy
- Keywords
- Healthy volunteer study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Oct 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 aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide/Formoterol Easyhaler A | Experimental | Drug: Budesonide, Drug: Formoterol, Device: Easyhaler |
| Budesonide/Formoterol Easyhaler B | Experimental | Drug: Budesonide, Drug: Formoterol, Device: Easyhaler |
| Budesonide/Formoterol Easyhaler C | Experimental | Drug: Budesonide, Drug: Formoterol, Device: Easyhaler |
| Budesonide/Formoterol Turbohaler Forte | Active comparator | Drug: Budesonide, Drug: Formoterol, Device: Turbohaler Forte |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females, 18-55 years of age.
- Normal weight at least 50 kg.
Key exclusion criteria (5 listed)
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
- Any 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.
- Known hypersensitivity to the active substance(s) or to any of the excipients 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 |
|---|---|---|
| BudesonideSingle inhalation | Drug | Budesonide/Formoterol Easyhaler A, Budesonide/Formoterol Easyhaler B, Budesonide/Formoterol Easyhaler C, Budesonide/Formoterol Turbohaler Forte |
| FormoterolSingle inhalation | Drug | Budesonide/Formoterol Easyhaler A, Budesonide/Formoterol Easyhaler B, Budesonide/Formoterol Easyhaler C, Budesonide/Formoterol Turbohaler Forte |
| EasyhalerInhaler device | Device | Budesonide/Formoterol Easyhaler A, Budesonide/Formoterol Easyhaler B, Budesonide/Formoterol Easyhaler C |
| Turbohaler ForteInhaler device | Device | Budesonide/Formoterol Turbohaler Forte |
Primary outcome
Cmax of Budesonide and Formoterol
Time frame: 24 hours
AUCt of Budesonide and Formoterol
Time frame: 24 hours
3 secondary outcomes
AUCinf of Budesonide and Formoterol
Time frame: 24 hours
tmax of Budesonide and Formoterol
Time frame: 24 hours
t1/2 of Budesonide and Formoterol
Time frame: 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 3 Feb 2012.
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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.
Johanna Hietamäki, 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 study testing Budesonide, Formoterol and Easyhaler in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Germany.
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 3 Feb 2012. 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 Germany. 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.
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 Budesonide and Formoterol (time frame: 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 3 Feb 2012.