AsthmaPhase 1REFLINCT01668121
Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
A Phase 1 study testing Symbicort Turbohaler and Budesonide/formoterol Easyhaler in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort Turbohaler and Budesonide/formoterol Easyhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Nov 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent (IC) obtained.
- Males and females, 18-55 (inclusive) years of age.
- Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2 (BMI= weight/height2).
- Weight at least 50 kg.
- Forced expiratory volume in one second (FEV1) at least 80% of the predicted value measured at the screening.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
Who cannot join
- Vulnerable subjects (i.e. persons under any administrative or legal supervision).
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease within previous 2 years; or evidence of active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed. The use of medicines which are strong CYP3A4 inducers or inhibitors are restricted for at least 2 weeks prior to the first study treatment administration and during the study.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator. More specifically, supine HR < 45 or > 100 bpm after 10-min rest or supine systolic BP >140 or < 90 or diastolic BP > 90 or < 60 mmHg after a 10-minute rest, or a QTc-Bazett (QTcB interval) > 450 msec at screening evaluation.
- Known hypersensitivity to the active substances or the excipient (lactose, which contains small amounts of milk protein) of the drug.
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- History of vasovagal collapses.
- History of anaphylactic/anaphylactoid reactions.
- History of seizures including febrile seizures.
- Pregnant or lactating females.
- Females of childbearing potential if they are not using proper contraception (mechanical and/or hormonal contraception, intrauterine device [IUD] or surgical sterilization). Double method of contraception is needed when using oral or mechanical contraception: e.g. condom in conjunct with oral contraception and spermicidal product with mechanical contraception (please see section 5.7 for details).
- Recent or current (suspected) drug abuse or positive result in the drugs abuse test.
- Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent]).
- Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study (from the screening visit to the end-of-study visit).
- Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration.
- Blood donation or loss of significant amount of blood within 30 days prior to the first study treatment administration.
- Administration of another investigational drug within 30 days prior to the first study treatment administration.
- Unsuitable veins for repeated venepuncture or for cannulation.
- Inability to learn the correct inhalation technique.
- Predictable poor compliance or inability to communicate well with the study centre personnel.
- Inability to participate in all treatment periods.
- The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Positive result in HIV, hepatitis B or C tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Two Batches of Symbicort Turbuhaler and Budesonide/Formoterol Easyhaler: Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler.
- Conditions
- Asthma
- Being tested
- Symbicort Turbohaler, Budesonide/formoterol Easyhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort TurbohalerDrug
Budesonide/formoterol EasyhalerDrug
| Study group | Role | What they receive |
|---|---|---|
| Symbicort Turbohaler | Experimental | Symbicort Turbohaler Receives: Drug: Symbicort Turbohaler; Drug: Budesonide/formoterol Easyhaler |
| Budesonide/formoterol Easyhaler | Active comparator | Budesonide/formoterol Easyhaler Receives: Drug: Symbicort Turbohaler; Drug: Budesonide/formoterol Easyhaler |
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: within 12 h
Pharmacokinetic parameter Cmax of plasma Formoterol concentration
Measured: within 24 h
Pharmacokinetic parameter AUCt of plasma Formoterol concentration
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 posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, MD, Principal investigator, ParexelMerja Mäkitalo, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668121
- Sponsor's protocol ID
- 3103012
- Acronym
- REFLI
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Two Batches of Symbicort Turbuhaler and Budesonide/Formoterol Easyhaler: Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01668121
- Acronym / sponsor ID
- REFLI / 3103012
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Aug 2012 (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 primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort Turbohaler | Experimental | Drug: Symbicort Turbohaler, Drug: Budesonide/formoterol EasyhalerSymbicort Turbohaler |
| Budesonide/formoterol Easyhaler | Active comparator | Drug: Symbicort Turbohaler, Drug: Budesonide/formoterol EasyhalerBudesonide/formoterol Easyhaler |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent (IC) obtained.
- Males and females, 18-55 (inclusive) years of age.
- Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2 (BMI= weight/height2).
- Weight at least 50 kg.
- Forced expiratory volume in one second (FEV1) at least 80% of the predicted value measured at the screening.
Key exclusion criteria (23 listed)
- Vulnerable subjects (i.e. persons under any administrative or legal supervision).
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease within previous 2 years; or evidence of active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed. The use of medicines which are strong CYP3A4 inducers or inhibitors are restricted for at least 2 weeks prior to the first study treatment administration and during the study.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator. More specifically, supine HR < 45 or > 100 bpm after 10-min rest or supine systolic BP >140 or < 90 or diastolic BP > 90 or < 60 mmHg after a 10-minute rest, or a QTc-Bazett (QTcB interval) > 450 msec at screening evaluation.
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 |
|---|---|---|
| Symbicort Turbohaler | Drug | Budesonide/formoterol Easyhaler, Symbicort Turbohaler |
| Budesonide/formoterol Easyhaler | Drug | Budesonide/formoterol Easyhaler, Symbicort Turbohaler |
Primary outcome
Pharmacokinetic parameter Cmax of plasma Budesonide concentration
Time frame: within 12 h
Pharmacokinetic parameter AUCt of plasma Budesonide concentration
Time frame: within 12 h
Pharmacokinetic parameter Cmax of plasma Formoterol concentration
Time frame: within 24 h
Pharmacokinetic parameter AUCt of plasma Formoterol concentration
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 27 Nov 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.
Rainard Fuhr, MD principal investigator
Parexel
Merja Mäkitalo 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 Symbicort Turbohaler and Budesonide/formoterol Easyhaler in people with Asthma, 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 6 inclusion and 23 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 27 Nov 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.
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 27 Nov 2012.