AsthmaPhase 1NCT00354042
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
A Phase 1 study testing GW597901X in people with Asthma, run by GlaxoSmithKline.
Trial summary
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW597901X
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with mild to moderate stable asthma but no other lung problems.
- Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
- Non-Smokers.
- Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.
Who cannot join
- Any significant illness.
- Subjects with heart problems.
- Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
- Subjects who take medication for their asthma, or other conditions, not compatible with this study.
- Subjects who are over sensitive to salbutamol or to ipratropium.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).
- Conditions
- Asthma
- Being tested
- GW597901X
- Keywords
- GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW597901XDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
Secondary outcomes (1)
Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
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 startAug 2004
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, MSc, FPPM, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354042
- Sponsor's protocol ID
- B2A100517
- Status last verified
- May 2009
- First submitted
- 18 Jul 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT00354042
- Acronym / sponsor ID
- B2A100517
- Conditions
- Asthma
- Keywords
- GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- 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 is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with mild to moderate stable asthma but no other lung problems.
- Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
- Non-Smokers.
- Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.
Key exclusion criteria (5 listed)
- Any significant illness.
- Subjects with heart problems.
- Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
- Subjects who take medication for their asthma, or other conditions, not compatible with this study.
- Subjects who are over sensitive to salbutamol or to ipratropium.
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 |
|---|---|---|
| GW597901X | Drug | – |
Primary outcome
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
1 secondary outcome
Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
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 18 May 2009.
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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, MD, MSc, FPPM study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW597901X in people with Asthma, run by GlaxoSmithKline.
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 5 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.. 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 18 May 2009; AzTrials last refreshed its copy on 8 Nov 2026.