Pulmonary Disease, Chronic ObstructivePhase 2NCT00358488
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
A Phase 2 study testing GSK159797 (10, 15, and 20mcg), salbutamol and salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 6 sites in 5 countries.
Trial summary
This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK159797 (10, 15, and 20mcg), salbutamol and salmeterol 50mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Apr 2006to Jan 2007
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
- Female subjects only using acceptable birth control method
- Non-smokers
- FEV1 between 60 and 90% predicted
- Increase in FEV1 12% or greater and 300mL and greater after salbutamol use
Who cannot join
- Past or present disease conditions
- Normal screening Holter ECG
- Respiratory tract infection within 4 weeks of screening
- History of life threatening asthma
- Previous use of COA
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Germany2 sites
GSK Investigational Site
Berlin, State of Berlin, 14057
GSK Investigational Site
Wiesbaden, Hesse, 65187
About this study
Official title: A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK159797 (10, 15, and 20mcg), salbutamol, salmeterol 50mcg, placebo
- Keywords
- Safety, Asthmatic patients, GSK159797, Efficacy
- 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.
GSK159797 (10, 15, and 20mcg)Drug
GSK159797 (10, 15, and 20mcg)
salbutamolDrug
salbutamol
salmeterol 50mcgDrug
salmeterol 50mcg
placeboDrug
Also called GSK159797 (10, 15, and 20mcg), salbutamol
placebo
| Study group | Role | What they receive |
|---|---|---|
| GSK159797 (10, 15, and 20mcg) | Experimental | GSK159797 (10, 15, and 20mcg) Receives: Drug: GSK159797 (10, 15, and 20mcg) |
| salbutamol | Experimental | salbutamol Receives: Drug: salbutamol |
| salmeterol 50mcg | Experimental | salmeterol 50mcg Receives: Drug: salmeterol 50mcg |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in trough FEV1
Measured: after 14 day repeat doses
Secondary outcomes (3)
Mean change from baseline in trough FEV1
Measured: after a single dose
Mean change from baseline in trough FEV1
Measured: after 7 days repeat dosing
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 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
- NCT00358488
- Sponsor's protocol ID
- B2E106359
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2006
- Last updated
- 28 Oct 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 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
- ClinicalTrials.gov ID
- NCT00358488
- Acronym / sponsor ID
- B2E106359
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Safety, Asthmatic patients, GSK159797, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 31 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 determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK159797 (10, 15, and 20mcg) | Experimental | Drug: GSK159797 (10, 15, and 20mcg)GSK159797 (10, 15, and 20mcg) |
| salbutamol | Experimental | Drug: salbutamolsalbutamol |
| salmeterol 50mcg | Experimental | Drug: salmeterol 50mcgsalmeterol 50mcg |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
- Female subjects only using acceptable birth control method
- Non-smokers
- FEV1 between 60 and 90% predicted
- Increase in FEV1 12% or greater and 300mL and greater after salbutamol use
Key exclusion criteria (5 listed)
- Past or present disease conditions
- Normal screening Holter ECG
- Respiratory tract infection within 4 weeks of screening
- History of life threatening asthma
- Previous use of COA
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 |
|---|---|---|
| GSK159797 (10, 15, and 20mcg)GSK159797 (10, 15, and 20mcg) | Drug | GSK159797 (10, 15, and 20mcg) |
| salbutamolsalbutamol | Drug | salbutamol |
| salmeterol 50mcgsalmeterol 50mcg | Drug | salmeterol 50mcg |
| placeboAlso: GSK159797 (10, 15, and 20mcg), salbutamolplacebo | Drug | placebo |
Primary outcome
Mean change from baseline in trough FEV1
Time frame: after 14 day repeat doses
3 secondary outcomes
Mean change from baseline in trough FEV1
Time frame: after a single dose
Mean change from baseline in trough FEV1
Time frame: after 7 days repeat dosing
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Time frame: Day 1 and Day 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 28 Oct 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
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK159797 (10, 15, and 20mcg), salbutamol and salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 6 sites in 5 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 5 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands, Russia, Sweden, 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 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?
Mean change from baseline in trough FEV1 (time frame: after 14 day repeat doses). 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 28 Oct 2016.