AsthmaPhase 1NCT00538057
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
A Phase 1 study testing GW685698X & GW642444M 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 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GW685698X & GW642444M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Oct 2007to 1 Dec 2007
- 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
- Healthy adults aged between 18 and 60 years.
- Male subjects or female subjects of non child bearing potential.
- Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive.
- No significant abnormality from ECG at screening.
- FEV1 at least 90% predicted and FEV1 / FVC ratio at least 0.7 at screening.
- 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 equal to or less than 5 pack years.
Who cannot join
- 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.
- 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.
- 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, ß2-agonist or sympathomimetic drug. gefitinib or erlotinib) is permitted. Use of bevacizumab must have ended at least 40 days prior to date of first dose of study drug.
- Any anti-cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy) currently or within 14 days prior to date of first dose of study drug.
- Any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1 and/or that is progressing in severity.
- Known immediate or delayed hypersensitivity reaction or idiosyncracy to drugs chemically related to pazopanib.
Trial locations and contacts
1 site in 1 country.
Australia1 site
GSK Investigational Site
Randwick, Sydney, New South Wales, 2031
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 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.
- Conditions
- Asthma
- Being tested
- GW685698X & GW642444M
- Keywords
- Healthy volunteers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698X & GW642444MDrug
study drug
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | study drug Receives: Drug: GW685698X & GW642444M |
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
Measured: changes over 12 hours.
Electrocardiogram
Measured: changes over 12 hours.
Change in peak expiry flow rate
Measured: changes over 24 hours.
Change in serum cortisol concentration
Measured: changes over 24 hours.
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study start2 Oct 2007
- Primary completion1 Dec 2007
- Study completion1 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT00538057
- Sponsor's protocol ID
- HZA105871
- Status last verified
- Aug 2017
- First submitted
- 1 Oct 2007
- Last updated
- 4 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
This study has not been published in the scientific literature.
Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5.
PubMed 27127998
Study at a glance
From the registry record, last updated by the sponsor on 4 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 Subjects
- ClinicalTrials.gov ID
- NCT00538057
- Acronym / sponsor ID
- HZA105871
- Conditions
- Asthma
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2007 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 2 Oct 2007 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: GW685698X & GW642444Mstudy drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults aged between 18 and 60 years.
- Male subjects or female subjects of non child bearing potential.
- Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive.
- No significant abnormality from ECG at screening.
- FEV1 at least 90% predicted and FEV1 / FVC ratio at least 0.7 at screening.
Key exclusion criteria (21 listed)
- 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 |
|---|---|---|
| GW685698X & GW642444Mstudy drug | Drug | arm 1 |
Primary outcome
Maximum heart rate
Time frame: over 4 hours after dosing.
Blood pressure
Time frame: changes over 12 hours.
Electrocardiogram
Time frame: changes over 12 hours.
Change in peak expiry flow rate
Time frame: changes over 24 hours.
Change in serum cortisol concentration
Time frame: changes over 24 hours.
3 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
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 4 Aug 2017.
- BackgroundThis study has not been published in the scientific literature.
- Derived from this study: PubMed 27127998Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5.
- 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 HZA105871 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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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.
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 GW685698X & GW642444M 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 6 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 4 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. 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 NCT00538057, which also lists 2 linked publications.
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 4 Aug 2017.