AsthmaPhase 1NCT00625196
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
A Phase 1 study testing Fluticasone foroate/ vilanterol, Fluticasone foroate and Vilanterol in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone foroate/ vilanterol, Fluticasone foroate and Vilanterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Feb 2008to 6 May 2008
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged between 20 and 60 years inclusive
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control method the female partner is using, from the first dose of study medication until 90 days after the last dose of study medication.
- Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese)
- Body weight ≥ 45 kg and body mass index within the range of 18-28 kg/m2 inclusive.
- No significant abnormality on 12-lead ECG at screening, including the following specific requirements:
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- Ventricular rate ≥ 45 beats per minute
- PR interval ≤ 210msec
- Q waves < 30msec (up to 50 ms permitted in lead III only)
- QRS interval to be ≥ 60msec and ≤ 120msec
- The waveforms must enable the QT interval to be clearly defined
- QTc interval must be < 450msec (QTcB or QTcF; machine or manual reading) based on a single ECG value, or an average from three ECGs obtained over a brief recording period
- No significant abnormality on the Holter ECG at screening.
- FEV1 ≥90% predicted and FEV1 / FVC ratio ≥ 0.7 at screening
- Subjects who are current non- smokers who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of < 5 pack years
- Signed and dated informed consent is obtained for the subject
- Subjects who are able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
- Subjects who are able to use the inhalation device satisfactorily
Who cannot join
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
- Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- History of milk protein allergy.
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- The subject has taken prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has taken oral corticosteroids less than 8 weeks before the screening visit
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
- History of alcohol/drug abuse or dependence within 12 months of the study
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a 285mL glass of full strength beer or 425mL schooner of light beer or 1 (30mL) measure of spirits or 1 glass (100mL) of wine
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- The subject has donated a unit (450mL) of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies.
- The subject has a positive pre-study urine drug screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- Positive CO or alcohol breath test at screening or on admission to the Unit.
- History of any adverse reaction including immediate or delayed hypersensitivity to any ICS, β2 agonist or sympathomimetic drug.
- Any known or suspected sensitivity to the constituents of GW642444M or GW685698X inhalation powder (i.e., lactose, magnesium stearate).
- Subjects at risk of non-compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Japanese Subjects
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound in healthy Japanese subjects.
- Conditions
- Asthma
- Being tested
- Fluticasone foroate/ vilanterol, Fluticasone foroate, Vilanterol, Placebo
- Keywords
- Healthy Japanese volunteers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone foroate/ vilanterolDrug
Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.
Fluticasone foroateDrug
Fluticasone foroate 800 micrograms will be available as dry powder inhaler.
VilanterolDrug
Vilanterol will be available as dry powder inhaler.
PlaceboDrug
Placebo will be supplied as dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving fluticasone foroate/ vilanterol | Experimental | Eligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler. There will be a washout period of 7 to 10 days between treatments. Receives: Drug: Fluticasone foroate/ vilanterol; Drug: Fluticasone foroate; Drug: Vilanterol |
| Subjects receiving fluticasone foroate | Active comparator | Eligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler. Receives: Drug: Fluticasone foroate |
| Subjects receiving vilanterol | Active comparator | Eligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler. Receives: Drug: Vilanterol |
| Subjects receiving placebo | Placebo comparator | Eligible subjects will receive single dose of placebo administered using a novel powder inhaler. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum heart rate
Measured: over 4 hours after dosing.
Blood pressure changes
Measured: over 12 hours.
Electrocardiogram changes
Measured: over 12 hours.
Change in peak expiry flow rate changes
Measured: over 24 hours.
Change in serum cortisol concentration changes
Measured: over 24 hours
Secondary outcomes (4)
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Measured: over 48 hours after dosing.
Change in blood potassium levels
Measured: within 4 hours of drug dosing.
Mean heart rate
Measured: over 4 hours after dosing
Plasma concentrations and derived pharmacokinetic parameters (AUC, Cmax,t½, tmax) for GW685698X, GW642444 and the GW642444 inactive metabolites GW630200 and GSK932009
Measured: over 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start27 Feb 2008
- Primary completion6 May 2008
- Study completion6 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625196
- Sponsor's protocol ID
- HZA102940
- Status last verified
- Aug 2017
- First submitted
- 19 Feb 2008
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Nakahara N, Wakamatsu A, Kempsford R, Allen A, Yamada M, Nohda S, Hirama T. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013 Aug;51(8):660-71. doi: 10.5414/CP201822.
PubMed 23735179
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT00625196
- Acronym / sponsor ID
- HZA102940
- Conditions
- Asthma
- Keywords
- Healthy Japanese volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2008 (actual)
- Primary completion
- 6 May 2008 (actual)
- Study completion
- 6 May 2008 (actual)
- First posted
- 28 Feb 2008 (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 combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound in healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving fluticasone foroate/ vilanterol | Experimental | Drug: Fluticasone foroate/ vilanterol, Drug: Fluticasone foroate, Drug: VilanterolEligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler. There will be a washout period of 7 to 10 days between treatments. |
| Subjects receiving fluticasone foroate | Active comparator | Drug: Fluticasone foroateEligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler. |
| Subjects receiving vilanterol | Active comparator | Drug: VilanterolEligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler. |
| Subjects receiving placebo | Placebo comparator | Drug: PlaceboEligible subjects will receive single dose of placebo administered using a novel powder inhaler. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy male adults aged between 20 and 60 years inclusive
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control method the female partner is using, from the first dose of study medication until 90 days after the last dose of study medication.
- Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese)
- Body weight ≥ 45 kg and body mass index within the range of 18-28 kg/m2 inclusive.
Key exclusion criteria (21 listed)
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
- Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
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 foroate/ vilanterolFluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler. | Drug | Subjects receiving fluticasone foroate/ vilanterol |
| Fluticasone foroateFluticasone foroate 800 micrograms will be available as dry powder inhaler. | Drug | Subjects receiving fluticasone foroate, Subjects receiving fluticasone foroate/ vilanterol |
| VilanterolVilanterol will be available as dry powder inhaler. | Drug | Subjects receiving fluticasone foroate/ vilanterol, Subjects receiving vilanterol |
| PlaceboPlacebo will be supplied as dry powder inhaler. | Drug | Subjects receiving placebo |
Primary outcome
Maximum heart rate
Time frame: over 4 hours after dosing.
Blood pressure changes
Time frame: over 12 hours.
Electrocardiogram changes
Time frame: over 12 hours.
Change in peak expiry flow rate changes
Time frame: over 24 hours.
Change in serum cortisol concentration changes
Time frame: over 24 hours
4 secondary outcomes
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Time frame: over 48 hours after dosing.
Change in blood potassium levels
Time frame: within 4 hours of drug dosing.
Mean heart rate
Time frame: over 4 hours after dosing
Plasma concentrations and derived pharmacokinetic parameters (AUC, Cmax,t½, tmax) for GW685698X, GW642444 and the GW642444 inactive metabolites GW630200 and GSK932009
Time frame: over 48 hours after dosing
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 21 Aug 2017.
- Background: PubMed 23735179Nakahara N, Wakamatsu A, Kempsford R, Allen A, Yamada M, Nohda S, Hirama T. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013 Aug;51(8):660-71. doi: 10.5414/CP201822.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study HZA102940 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 foroate/ vilanterol, Fluticasone foroate and Vilanterol in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.
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 18 inclusion and 21 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 21 Aug 2017. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Maximum heart rate (time frame: over 4 hours after dosing.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00625196, which also lists 1 linked publication.
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 21 Aug 2017.