AsthmaPhase 1NCT02403713
A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers
A Phase 1 study testing Fluticasone/formoterol BAI, Formoterol and Fluticasone/formoterol PMDI without spacer in people with Asthma, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone/formoterol BAI, Formoterol and Fluticasone/formoterol PMDI without spacer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Sep 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or over.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- Normal lung function (FEV1 >90% of predicted normal value).
- Demonstrate satisfactory technique in the use of the study drug devices.
- No use of steroid medication (systemic or topical) within 8 weeks prior to study screening.
Who cannot join
- Subjects who use any asthma medication or are knowingly regularly exposed to asthma medication.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- History of asthma, COPD, or other bronchial or lung diseases.
- User of steroid medication (systemic or topical) within 8 weeks prior to study screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-label, 2-group PK (3-period) and PD (5-period) Crossover Study to Compare Systemic Exposure and Pharmacodynamic Effects of Fluticasone/Formoterol BAI and pMDI in Healthy Volunteers
A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.
Read the detailed description
Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. PK interim analysis to determine requirement for PK extension.
Group 1 (PK) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. Results from PK stage will determine if Group 2 (PD) is required. Group 2 (PD) will assess LABA only effects (as confirmed in interim analysis).
Group 2 (PD) to include 2 overnight stays for 5 study periods. Volunteers will receive a single dose of study medication, with discharge on Day 2.
Study treatments are fluticasone/formoterol BAI, fluticasone/formoterol pMDI with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer.
Volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.
- Conditions
- Asthma
- Being tested
- Fluticasone/formoterol BAI, Formoterol, Fluticasone/formoterol PMDI without spacer, Fluticasone/formoterol PMDI with spacer, Fluticasone/formoterol PMDI without spacer low dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone/formoterol BAIDrug
Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
FormoterolDrug
Formoterol
Fluticasone/formoterol PMDI without spacerDrug
Fluticasone/Formoteral 125/5µg pMDI without spacer
Fluticasone/formoterol PMDI with spacerDrug
Fluticasone/Formoteral 125/5µg pMDI with spacer
Fluticasone/formoterol PMDI without spacer low doseDrug
Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment | Experimental | Fluticasone/formoterol 125/5 µg BAI Receives: Drug: Fluticasone/formoterol BAI |
| Active Comparator 1 | Active comparator | Fluticasone/formoterol 125/5 µg pMDI with spacer Receives: Drug: Fluticasone/formoterol PMDI with spacer |
| Active Comparator 2 | Active comparator | Fluticasone/formoterol 125/5 µg pMDI without spacer Receives: Drug: Fluticasone/formoterol PMDI without spacer |
| Active Comparator 3 | Active comparator | Fluticasone/formoterol pMDI (125/5 μg) without spacer, low dose Receives: Drug: Fluticasone/formoterol PMDI without spacer low dose |
| Active Comparator 4 | Active comparator | Formoterol (12 µg) without spacer Receives: Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
Measured: Pre dose to 36 hours post dose
Serum Potassium
Maximum reduction in serum potassium from pre-dose.
Measured: Pre Dose to 6 hours post first dose
Secondary outcomes (2)
Vital Signs
Composite measurement of vital signs (heart rate and blood pressure)
Measured: Pre Dose to 6 hours post dose
Serum Glucose
Maximum increase in Serum Glucose
Measured: Pre Dose to 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionSep 2015
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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403713
- Sponsor's protocol ID
- KFL1503
- Other IDs
- 2013-000045-39
- Status last verified
- Sep 2015
- First submitted
- 19 Feb 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, 2-group PK (3-period) and PD (5-period) Crossover Study to Compare Systemic Exposure and Pharmacodynamic Effects of Fluticasone/Formoterol BAI and pMDI in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02403713
- Acronym / sponsor ID
- KFL1503
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Mar 2015 (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.
A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.
Detailed description
Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. PK interim analysis to determine requirement for PK extension.
Group 1 (PK) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. Results from PK stage will determine if Group 2 (PD) is required. Group 2 (PD) will assess LABA only effects (as confirmed in interim analysis).
Group 2 (PD) to include 2 overnight stays for 5 study periods. Volunteers will receive a single dose of study medication, with discharge on Day 2.
Study treatments are fluticasone/formoterol BAI, fluticasone/formoterol pMDI with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer.
Volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Test Treatment | Experimental | Drug: Fluticasone/formoterol BAIFluticasone/formoterol 125/5 µg BAI |
| Active Comparator 1 | Active comparator | Drug: Fluticasone/formoterol PMDI with spacerFluticasone/formoterol 125/5 µg pMDI with spacer |
| Active Comparator 2 | Active comparator | Drug: Fluticasone/formoterol PMDI without spacerFluticasone/formoterol 125/5 µg pMDI without spacer |
| Active Comparator 3 | Active comparator | Drug: Fluticasone/formoterol PMDI without spacer low doseFluticasone/formoterol pMDI (125/5 μg) without spacer, low dose |
| Active Comparator 4 | Active comparator | Drug: FormoterolFormoterol (12 µg) without spacer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 years or over.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- Normal lung function (FEV1 >90% of predicted normal value).
- Demonstrate satisfactory technique in the use of the study drug devices.
- No use of steroid medication (systemic or topical) within 8 weeks prior to study screening.
Key exclusion criteria (5 listed)
- Subjects who use any asthma medication or are knowingly regularly exposed to asthma medication.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- History of asthma, COPD, or other bronchial or lung diseases.
- User of steroid medication (systemic or topical) within 8 weeks prior to study screening.
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 |
|---|---|---|
| Fluticasone/formoterol BAIFluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose) | Drug | Test Treatment |
| FormoterolFormoterol | Drug | Active Comparator 4 |
| Fluticasone/formoterol PMDI without spacerFluticasone/Formoteral 125/5µg pMDI without spacer | Drug | Active Comparator 2 |
| Fluticasone/formoterol PMDI with spacerFluticasone/Formoteral 125/5µg pMDI with spacer | Drug | Active Comparator 1 |
| Fluticasone/formoterol PMDI without spacer low doseFluticasone/Formoteral 125/5µg pMDI without spacer, low dose | Drug | Active Comparator 3 |
Primary outcome
Pharmacokinetic parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF).
Time frame: Pre dose to 36 hours post dose
Serum Potassium
Time frame: Pre Dose to 6 hours post first dose
Maximum reduction in serum potassium from pre-dose.
2 secondary outcomes
Vital Signs
Time frame: Pre Dose to 6 hours post dose
Serum Glucose
Time frame: Pre Dose to 6 hours post dose
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 28 Sep 2015.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluticasone/formoterol BAI, Formoterol and Fluticasone/formoterol PMDI without spacer in people with Asthma, run by Mundipharma Research Limited 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 5 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 28 Sep 2015. 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 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 parameters Composite measurement of Pharmacokinetic parameters (Cmax, AUCt, AUCINF). (time frame: Pre dose to 36 hours post dose). 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 28 Sep 2015.