Pulmonary Disease, Chronic ObstructivePhase 1NCT00463697
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
A Phase 1 study testing GW642444H (100mcg) and GW642444M (25, 100 & 400 mcg) in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GW642444H (100mcg) and GW642444M (25, 100 & 400 mcg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Apr 2007to 4 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female (of non-childbearing potential) between 18 - 70 years
- History of stable mild to moderate asthma
- non - smokers
- currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
- body weight >50 kg with BMI 19-29.9 kg/m2
- normal ECG assessment
Who cannot join
- history of significant disease
- history of life threatening asthma
- recent respiratory tract infection
- recent change of asthma medication
- treatment with high dose inhaled corticosteroids or oral corticosteroids
- recent participation in another trial
Show all 9Show fewer
- history of drug or alcohol abuse
- known allergies (excluding asthma)
- recent blood donation
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
Harrow, Middlesex, HA1 3UJ
GSK Investigational Site
London, SE1 1YR
GSK Investigational Site
Manchester, M23 9QZ
About this study
Official title: A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and 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 previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).
Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GW642444H (100mcg), placebo, GW642444M (25, 100 & 400 mcg)
- Keywords
- GW642444,, magnesium stearate,, asthmatic patients
- 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.
GW642444H (100mcg)Drug
H salt
placeboDrug
placebo
GW642444M (25, 100 & 400 mcg)Drug
Also called placebo, GW642444M (25, 100 & 400 mcg), GW642444H (100mcg)
M salt
| Study group | Role | What they receive |
|---|---|---|
| GW642444M 25mcg | Experimental | Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning. Receives: Drug: GW642444M (25, 100 & 400 mcg) |
| GW642444M 100mcg | Experimental | Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning. Receives: Drug: GW642444M (25, 100 & 400 mcg) |
| GW642444M 400mcg | Experimental | Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning. Receives: Drug: GW642444M (25, 100 & 400 mcg) |
| GW642444H 100mcg | Experimental | Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning. Receives: Drug: GW642444H (100mcg) |
| placebo | Placebo comparator | Subject will inhale single dose of Placebo via a DISKUS device in morning. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Measured: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Secondary outcomes (1)
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Measured: Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study start2 Apr 2007
- Primary completion4 Aug 2007
- Study completion4 Aug 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT00463697
- Sponsor's protocol ID
- B2C106996
- Status last verified
- Aug 2017
- First submitted
- 18 Apr 2007
- Last updated
- 7 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 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00463697
- Acronym / sponsor ID
- B2C106996
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GW642444,, magnesium stearate,, asthmatic patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2007 (actual)
- Primary completion
- 4 Aug 2007 (actual)
- Study completion
- 4 Aug 2007 (actual)
- First posted
- 20 Apr 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.
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and 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 previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).
Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GW642444M 25mcg | Experimental | Drug: GW642444M (25, 100 & 400 mcg)Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning. |
| GW642444M 100mcg | Experimental | Drug: GW642444M (25, 100 & 400 mcg)Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning. |
| GW642444M 400mcg | Experimental | Drug: GW642444M (25, 100 & 400 mcg)Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning. |
| GW642444H 100mcg | Experimental | Drug: GW642444H (100mcg)Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning. |
| placebo | Placebo comparator | Drug: placeboSubject will inhale single dose of Placebo via a DISKUS device in morning. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female (of non-childbearing potential) between 18 - 70 years
- History of stable mild to moderate asthma
- non - smokers
- currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
- body weight >50 kg with BMI 19-29.9 kg/m2
Key exclusion criteria (9 listed)
- history of significant disease
- history of life threatening asthma
- recent respiratory tract infection
- recent change of asthma medication
- treatment with high dose inhaled corticosteroids or oral corticosteroids
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 |
|---|---|---|
| GW642444H (100mcg)H salt | Drug | GW642444H 100mcg |
| placeboplacebo | Drug | placebo |
| GW642444M (25, 100 & 400 mcg)Also: placebo, GW642444M (25, 100 & 400 mcg), GW642444H (100mcg)M salt | Drug | GW642444M 100mcg, GW642444M 25mcg, GW642444M 400mcg |
Primary outcome
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Time frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
1 secondary outcome
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Time frame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
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 7 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.
- Results for study B2C106996 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW642444H (100mcg) and GW642444M (25, 100 & 400 mcg) in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites 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 6 inclusion and 9 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 7 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 3 sites 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. 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?
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). (time frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).). 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 NCT00463697, 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 7 Aug 2017.