AsthmaPhase 1Reco-PilotNCT01181063
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
A Phase 1 study testing Budesonide/formoterol 320/9 μg and 400/12 μg inhalers in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known. 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 320/9 μg and 400/12 μg inhalers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2010to Nov 2010
- 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 (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males and females, 18-60 (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
- Hemoglobin 135-195 g/l male, 125-175 g/l female.
Who cannot join
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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 the study.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed.
- 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.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- History of vasovagal collapses.
Show all 20Show fewer
- History of anaphylactic/anaphylactoid reactions.
- History of seizures including febrile seizures.
- Pregnant or lactating females.
- Females of childbearing potential not using proper contraception (mechanical and/or hormonal contraception, intrauterine device [IUD] or surgical sterilization) Note: Females of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator.
- 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 24h after study treatment administration.
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
- Administration of another investigational drug within 90 days prior to the first study treatment administration.
- Unsuitable veins for repeated venipuncture or for cannulation.
- Inability to learn the correct inhalation technique (during screening or on a separate visit for training).
- Predictable poor compliance or inability to communicate well with the study centre personnel.
- Inability to participate in all treatment periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Easyhalers and Symbicort Turbuhaler; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects
Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known.
The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.
Read the detailed description
In order to reduce variability, a crossover design is chosen. An open study design is regarded appropriate because the study is a pilot and the primary study variables are pharmacokinetic(PK) parameters derived from drug concentrations in plasma. Wash-out period of at least 3 days between the study treatment administration days is considered sufficient for the elimination of budesonide and formoterol.
The single dose study is suitable for this kind of study, where the aim is to compare products and the therapeutic response is not measured.
The dose level selected is 2 inhalations (single dose) for all products. The administration of 2 inhalations enables the determination of budesonide and formoterol concentrations in plasma.
In this study the investigational products are administered concomitantly with oral charcoal to block the GI absorption and to assess the pulmonary deposition of the active substances.
Comparison of pulmonary deposition between the products is considered more relevant than systemic exposure at this point of product development. In the pivotal PK study total systemic exposure will also be assessed.
Blood samples for formoterol analysis will be collected up to 24 hours and for budesonide analysis up to 12 hours after dosing to cover at least 80% of the total area under the concentration-time curve from time zero extrapolated to infinity (AUC∞).
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
- Keywords
- Asthma, Easyhaler
- 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 320/9 μg and 400/12 μg inhalersDrug
Also called Symbicort 320/9 μg inhaler
Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product
| Study group | Role | What they receive |
|---|---|---|
| 400/12 μg D94-2BF (60/40) inhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2BF (20/80) inhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| Symbicort 320/9 μg inhaler | Active comparator | Not described Receives: Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2F (60/40) inhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2BF (60/40) inhaler | Experimental | Not described Receives: Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum observed concentration of concentration-time curve.
Measured: 24 hours
Secondary outcomes (1)
The area under the concentration-time curve from time zero to infinity, AUC∞
The area under the concentration-time curve from time zero to infinity will be determined by adding AUCt to the extrapolated area that will be determined dividing the last quantifiable concentration by terminal elimination rate constant from log-linear portion of a concentration-time curve
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 posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionNov 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
- 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)
- Investigators
- Kimmo Ingman, MD, PhD, Principal investigator, Phase I Unit, Orion Pharma, Espoo, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181063
- Sponsor's protocol ID
- 3103005
- Acronym
- Reco-Pilot
- Status last verified
- Jun 2011
- First submitted
- 12 Aug 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Pilot Study on Budesonide/Formoterol Easyhalers and Symbicort Turbuhaler; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01181063
- Acronym / sponsor ID
- Reco-Pilot / 3103005
- Conditions
- Asthma
- Keywords
- Asthma, Easyhaler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Aug 2010 (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.
Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known.
The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.
Detailed description
In order to reduce variability, a crossover design is chosen. An open study design is regarded appropriate because the study is a pilot and the primary study variables are pharmacokinetic(PK) parameters derived from drug concentrations in plasma. Wash-out period of at least 3 days between the study treatment administration days is considered sufficient for the elimination of budesonide and formoterol.
The single dose study is suitable for this kind of study, where the aim is to compare products and the therapeutic response is not measured.
The dose level selected is 2 inhalations (single dose) for all products. The administration of 2 inhalations enables the determination of budesonide and formoterol concentrations in plasma.
In this study the investigational products are administered concomitantly with oral charcoal to block the GI absorption and to assess the pulmonary deposition of the active substances.
Comparison of pulmonary deposition between the products is considered more relevant than systemic exposure at this point of product development. In the pivotal PK study total systemic exposure will also be assessed.
Blood samples for formoterol analysis will be collected up to 24 hours and for budesonide analysis up to 12 hours after dosing to cover at least 80% of the total area under the concentration-time curve from time zero extrapolated to infinity (AUC∞).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 400/12 μg D94-2BF (60/40) inhaler | Experimental | Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2BF (20/80) inhaler | Experimental | Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| Symbicort 320/9 μg inhaler | Active comparator | Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2F (60/40) inhaler | Experimental | Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
| 320/9 μg D94-2BF (60/40) inhaler | Experimental | Drug: Budesonide/formoterol 320/9 μg and 400/12 μg inhalers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males and females, 18-60 (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
Key exclusion criteria (20 listed)
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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 the study.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed.
- 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.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
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 320/9 μg and 400/12 μg inhalersAlso: Symbicort 320/9 μg inhalerBudesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product | Drug | 320/9 μg D94-2BF (20/80) inhaler, 320/9 μg D94-2BF (60/40) inhaler, 320/9 μg D94-2F (60/40) inhaler, 400/12 μg D94-2BF (60/40) inhaler, Symbicort 320/9 μg inhaler |
Primary outcome
The maximum observed concentration of concentration-time curve.
Time frame: 24 hours
1 secondary outcome
The area under the concentration-time curve from time zero to infinity, AUC∞
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 10 Jun 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.
Kimmo Ingman, MD, PhD principal investigator
Phase I Unit, Orion Pharma, 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 320/9 μg and 400/12 μg inhalers 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 6 inclusion and 20 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 10 Jun 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?
The maximum observed concentration of concentration-time curve. (time frame: 24 hours). 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 10 Jun 2011.