Pulmonary Disease, Chronic ObstructivePhase 1NCT00469040
Safety, Blood Levels and Effects of GW642444
A Phase 1 study testing GW642444M for 14 days in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GW642444M for 14 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2007to 16 Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males and females (of non-childbearing potential) aged 18-55
- body weight >50kg with BMI 19-29.9 kg/m2
- normal ECG recording
- non-smoker
Who cannot join
- high blood pressure (above 140/90 mmHg)
- pulse outside range 45 - 90 bpm
- history of breathing problems e.g. asthma
- low haemoglobin (<11 g/dL)
- blood donation within 56 days of study start
- taking regular medication
Show all 10Show fewer
- participation in another trial within 4 months of study start
- history of drug or alcohol abuse
- abnormal clinical laboratory tests
- known allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects
GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.
When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.
Read more
We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.
1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GW642444M for 14 days
- Keywords
- GW642444,, healthy subjects, magnesium stearate,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW642444M for 14 daysDrug
Also called GW642444 (25, 50, 100, 200 & 400 mcg) for 14 days
M salt
| Study group | Role | What they receive |
|---|---|---|
| GW642444M 25mcg | Experimental | In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg. Receives: Drug: GW642444M for 14 days |
| GW642444M 50mcg | Experimental | Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1. Receives: Drug: GW642444M for 14 days |
| GW642444M 100mcg | Experimental | In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg. Receives: Drug: GW642444M for 14 days |
| GW642444M 200mcg | Experimental | Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2. Receives: Drug: GW642444M for 14 days |
| GW642444M 400mcg | Experimental | Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3. Receives: Drug: GW642444M for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14
Measured: Repeated measures on Day 1, 7 and 14
Secondary outcomes (1)
Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14
Measured: Repeated measures on Day 1, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study start28 Feb 2007
- Primary completion16 Apr 2007
- Study completion16 Apr 2007
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 Pulmonary Disease, Chronic ObstructiveStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT00469040
- Sponsor's protocol ID
- B2C108784
- Status last verified
- Aug 2017
- First submitted
- 3 May 2007
- Last updated
- 4 Aug 2017
- Results posted
- 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
Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.
PubMed 23232038
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, Parallel-group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00469040
- Acronym / sponsor ID
- B2C108784
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GW642444,, healthy subjects, magnesium stearate,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2007 (actual)
- Primary completion
- 16 Apr 2007 (actual)
- Study completion
- 16 Apr 2007 (actual)
- First posted
- 4 May 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.
GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.
When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.
We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.
1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GW642444M 25mcg | Experimental | Drug: GW642444M for 14 daysIn Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg. |
| GW642444M 50mcg | Experimental | Drug: GW642444M for 14 daysSubjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1. |
| GW642444M 100mcg | Experimental | Drug: GW642444M for 14 daysIn Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg. |
| GW642444M 200mcg | Experimental | Drug: GW642444M for 14 daysSubjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2. |
| GW642444M 400mcg | Experimental | Drug: GW642444M for 14 daysSubjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy males and females (of non-childbearing potential) aged 18-55
- body weight >50kg with BMI 19-29.9 kg/m2
- normal ECG recording
- non-smoker
Key exclusion criteria (10 listed)
- high blood pressure (above 140/90 mmHg)
- pulse outside range 45 - 90 bpm
- history of breathing problems e.g. asthma
- low haemoglobin (<11 g/dL)
- blood donation within 56 days of study start
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 |
|---|---|---|
| GW642444M for 14 daysAlso: GW642444 (25, 50, 100, 200 & 400 mcg) for 14 daysM salt | Drug | GW642444M 100mcg, GW642444M 200mcg, GW642444M 25mcg, GW642444M 400mcg, GW642444M 50mcg |
Primary outcome
General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14
Time frame: Repeated measures on Day 1, 7 and 14
1 secondary outcome
Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14
Time frame: Repeated measures on Day 1, 7 and 14
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.
- Background: PubMed 23232038Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.
- 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 B2C108784 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 GW642444M for 14 days in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline 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 4 inclusion and 10 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 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?
General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14 (time frame: Repeated measures on Day 1, 7 and 14). 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 NCT00469040, 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 4 Aug 2017.