AsthmaPhase 2NCT00354874
Investigation Of A New Medication (GW642444) In Asthmatic Patients
A Phase 2 study testing GW642444 and salmeterol 50mcg in people with Asthma, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW642444 and salmeterol 50mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2005to Jun 2005
- Phase
- Phase 2
- 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
- Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
- Non-smokers for at least 6 months.
- Stable asthma.
Who cannot join
- Abnormal findings on heart monitoring assessment.
- Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
- Currently taking doses of fluticasone propionate over 500mcg/day.
- Unstable asthma medication.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Wiesbaden, Hesse, 65187
About this study
Official title: A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444
This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.
Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
- Conditions
- Asthma
- Being tested
- GW642444, Placebo, salmeterol 50mcg
- Keywords
- GW642444 asthmatic subjects safety tolerability PD and PK
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW642444Drug
drug
PlaceboDrug
placebo
salmeterol 50mcgDrug
salmeterol
| Study group | Role | What they receive |
|---|---|---|
| GW642444 50mcg | Experimental | Not described Receives: Drug: GW642444 |
| GW642444 100mcg | Experimental | Not described Receives: Drug: GW642444 |
| GW642444 200mcg | Experimental | Not described Receives: Drug: GW642444 |
| salmeterol 50mcg | Active comparator | Not described Receives: Drug: salmeterol 50mcg |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 at 24 hours after a single dose.
Measured: 24 hours on 4 separate occasions
Secondary outcomes (6)
FEV1 - Days 1 and 7
Measured: Days 1 and 7 on 4 separate occasions
Mean morning/evening PEFR
Measured: Days 3-8 on 4 separate occasions
BP, HR & QTc on Days 1 and 7
Measured: Days 1 and 7 on 4 separate occasions
Potassium and glucose on Days 1 and 7
Measured: Days 1 and 7 on 4 separate occasions
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
Measured: throughout study
PK parameters
Measured: Days 1, 4 and 7 on 4 separate occasions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2005
- Study completionJun 2005
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT00354874
- Sponsor's protocol ID
- B2C101762
- Status last verified
- Sep 2016
- First submitted
- 18 Jul 2006
- Last updated
- 15 Sep 2016
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444
- ClinicalTrials.gov ID
- NCT00354874
- Acronym / sponsor ID
- B2C101762
- Conditions
- Asthma
- Keywords
- GW642444 asthmatic subjects safety tolerability PD and PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 20 Jul 2006 (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 evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.
Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GW642444 50mcg | Experimental | Drug: GW642444 |
| GW642444 100mcg | Experimental | Drug: GW642444 |
| GW642444 200mcg | Experimental | Drug: GW642444 |
| salmeterol 50mcg | Active comparator | Drug: salmeterol 50mcg |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
- Non-smokers for at least 6 months.
- Stable asthma.
Key exclusion criteria (4 listed)
- Abnormal findings on heart monitoring assessment.
- Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
- Currently taking doses of fluticasone propionate over 500mcg/day.
- Unstable asthma medication.
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 |
|---|---|---|
| GW642444drug | Drug | GW642444 100mcg, GW642444 200mcg, GW642444 50mcg |
| Placeboplacebo | Drug | placebo |
| salmeterol 50mcgsalmeterol | Drug | salmeterol 50mcg |
Primary outcome
FEV1 at 24 hours after a single dose.
Time frame: 24 hours on 4 separate occasions
6 secondary outcomes
FEV1 - Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
Mean morning/evening PEFR
Time frame: Days 3-8 on 4 separate occasions
BP, HR & QTc on Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
Potassium and glucose on Days 1 and 7
Time frame: Days 1 and 7 on 4 separate occasions
safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
Time frame: throughout study
PK parameters
Time frame: Days 1, 4 and 7 on 4 separate occasions
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 15 Sep 2016.
- 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW642444 and salmeterol 50mcg in people with Asthma, run by GlaxoSmithKline at 3 sites in 2 countries.
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 3 inclusion and 4 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 15 Sep 2016. 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 Germany, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
FEV1 at 24 hours after a single dose. (time frame: 24 hours on 4 separate occasions). 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 15 Sep 2016.