Pulmonary Disease, Chronic ObstructivePhase 2NCT00347139
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
A Phase 2 study testing GW642444 (25, 100 & 400 mcg/day) and Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 7 sites in 5 countries.
Trial summary
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). 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?
- GW642444 (25, 100 & 400 mcg/day) and Salmeterol 50mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 23 May 2006to 10 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a documented history of persistent asthma.
- Current non-smokers.
- Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
- Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.
Who cannot join
- Subjects with significant past or present disease which which may affect their safety.
- Upper or lower respiratory tract infection within 4 weeks of screening.
- History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
- Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
- Patients weighing less than 50kg.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Wiesbaden, Hesse, 65187
Sweden2 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Stockholm, SE-141 86
About this study
Official title: Multi-centre, Randomised, 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 (25, 100 and 400 mcg Once Daily) of GW642444
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GW642444 (25, 100 & 400 mcg/day), Salmeterol 50mcg
- Keywords
- Tolerability, Pharmacodynamics, Safety, Pharmacokinetics, GW642444, Asthmatic patients, 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.
GW642444 (25, 100 & 400 mcg/day)Drug
25, 100 and 400mcg/dose
Salmeterol 50mcgDrug
Salmeterol 50mcg
| Study group | Role | What they receive |
|---|---|---|
| GW642444 | Experimental | Not described Receives: Drug: GW642444 (25, 100 & 400 mcg/day) |
| Salmeterol | Active comparator | Not described Receives: Drug: Salmeterol 50mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days
The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.
Measured: From Baseline (pre-dose on Day 1) and up to 14 days
Secondary outcomes (7)
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose value recorded on Day 1. Weighted means have been presented as least square means. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient.
Measured: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline AM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Measured: Baseline (pre-dose on Day 1) and up to 15 days
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Measured: Baseline (pre-dose on Day 1) and up to 14 days
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM FEV1 values were measured by electronic flow meter and was measured in the morning over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline AM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Measured: Baseline (pre-dose on Day 1), Day 2, and Day 15
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM FEV1 values were measured by electronic flow meter and was measured in the evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Measured: Baseline (pre-dose on Day 1) and up to Day 14
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-AM PEFR is the value at indicated time point minus the pre-AM PEFR value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period.
Measured: Day 1, 7, and 14
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-PM PEFR is the value at indicated time point minus the pre-PM PEFR value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each morning, over period.
Measured: 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 Jul 2006 (estimated)
- Study start23 May 2006
- Primary completion10 Jan 2007
- Study completion10 Jan 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 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
- NCT00347139
- Sponsor's protocol ID
- B2C106093
- Status last verified
- Sep 2017
- First submitted
- 29 Jun 2006
- Last updated
- 14 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomised, 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 (25, 100 and 400 mcg Once Daily) of GW642444
- ClinicalTrials.gov ID
- NCT00347139
- Acronym / sponsor ID
- B2C106093
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Tolerability, Pharmacodynamics, Safety, Pharmacokinetics, GW642444, Asthmatic patients, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 May 2006 (actual)
- Primary completion
- 10 Jan 2007 (actual)
- Study completion
- 10 Jan 2007 (actual)
- First posted
- 4 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.
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GW642444 | Experimental | Drug: GW642444 (25, 100 & 400 mcg/day) |
| Salmeterol | Active comparator | Drug: Salmeterol 50mcg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a documented history of persistent asthma.
- Current non-smokers.
- Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
- Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.
Key exclusion criteria (5 listed)
- Subjects with significant past or present disease which which may affect their safety.
- Upper or lower respiratory tract infection within 4 weeks of screening.
- History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
- Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
- Patients weighing less than 50kg.
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 |
|---|---|---|
| GW642444 (25, 100 & 400 mcg/day)25, 100 and 400mcg/dose | Drug | GW642444 |
| Salmeterol 50mcgSalmeterol 50mcg | Drug | Salmeterol |
Primary outcome
Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days
Time frame: From Baseline (pre-dose on Day 1) and up to 14 days
The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.
7 secondary outcomes
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
Time frame: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
Time frame: Baseline (pre-dose on Day 1) and up to 15 days
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
Time frame: Baseline (pre-dose on Day 1) and up to 14 days
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
Time frame: Baseline (pre-dose on Day 1), Day 2, and Day 15
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
Time frame: Baseline (pre-dose on Day 1) and up to Day 14
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
Time frame: Day 1, 7, and 14
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
Time frame: 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 14 Sep 2017.
- 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
7 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 GW642444 (25, 100 & 400 mcg/day) and Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 7 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 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Sweden, New Zealand, Russia, 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 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 (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days (time frame: From Baseline (pre-dose on Day 1) and up to 14 days). 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 14 Sep 2017.