Pulmonary Disease, Chronic ObstructivePhase 2NCT00381667
Study to Assess GW642444 in Asthma Patients
A Phase 2 study testing GW642444M and GW642444H in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent… 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?
- GW642444M and GW642444H
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases
- Female subjects of non-child bearing potential (i.e. post-menopausal or surgically sterile)
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than 10 pack years.
- Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than 12.0% over baseline and an absolute change of greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.
- Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS
Who cannot join
- Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of 4 beats, R on T phenomena, bigeminy, trigeminy).
- A mean QTc(B) value at screening >430 msec (male) / >450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose or COA).
- Subjects weighing < 50 kg
- Subjects who have participated in any GSK study involving administration of COA.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Dose Ascending, Five-way Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses (25, 100 and 400 µg) of GW642444M
This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.
Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GW642444M, GW642444H, placebo
- Keywords
- safety, GW642444M, Single Dose, pharmacodynamics, pharmacokinetics, GW642444H, tolerability
- 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.
GW642444MDrug
Also called GW642444
M salt
GW642444HDrug
H salt
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| GW642444M 12.5 | Experimental | Not described Receives: Drug: GW642444M |
| GW642444M 100mcg | Experimental | Not described Receives: Drug: GW642444M |
| GW642444M 400mcg | Experimental | Not described Receives: Drug: GW642444M |
| GW642444H 100mcg | Experimental | Not described Receives: Drug: GW642444H |
| Placebo | Experimental | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: throughout study
Laboratory safety tests
Measured: throughout study
Holter monitoring
Measured: throughout study
Vital signs and 12-lead ECG)
Measured: throughout study
Mean change from baseline FEV1 24 hours after dosing.
Measured: Day 1, on 5 separate occasions
Supine systolic and diastolic blood pressure and supine heart rate
Measured: Day 1 on 5 separate occasions
QTc(B)and QTc(F)
Measured: Day 1 on 5 separate occasions
Secondary outcomes (5)
Potassium Max decrease from baseline
Measured: Day 1 on 5 separate occasions
Mean change from baseline(0-4h)potassium.
Measured: Day 1 on 5 separate occasions
Glucose Max increase from baseline
Measured: Day 1 on 5 separate occasions
Weighted mean change from baseline (0-4h)glucose
Measured: Day 1 on 5 separate occasions
Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR
Measured: Day 1 on 5 separate occasions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startAug 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
- 14 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
- NCT00381667
- Sponsor's protocol ID
- B2C104604
- Status last verified
- Oct 2016
- First submitted
- 26 Sep 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 Randomised, Double-blind, Placebo-controlled, Dose Ascending, Five-way Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses (25, 100 and 400 µg) of GW642444M
- ClinicalTrials.gov ID
- NCT00381667
- Acronym / sponsor ID
- B2C104604
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- safety, GW642444M, Single Dose, pharmacodynamics, pharmacokinetics, GW642444H, tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 28 Sep 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 is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.
Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events 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 |
|---|---|---|
| GW642444M 12.5 | Experimental | Drug: GW642444M |
| GW642444M 100mcg | Experimental | Drug: GW642444M |
| GW642444M 400mcg | Experimental | Drug: GW642444M |
| GW642444H 100mcg | Experimental | Drug: GW642444H |
| Placebo | Experimental | Other: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases
- Female subjects of non-child bearing potential (i.e. post-menopausal or surgically sterile)
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than 10 pack years.
- Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than 12.0% over baseline and an absolute change of greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.
Key exclusion criteria (6 listed)
- Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of 4 beats, R on T phenomena, bigeminy, trigeminy).
- A mean QTc(B) value at screening >430 msec (male) / >450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose or COA).
- Subjects weighing < 50 kg
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 |
|---|---|---|
| GW642444MAlso: GW642444M salt | Drug | GW642444M 100mcg, GW642444M 12.5, GW642444M 400mcg |
| GW642444HH salt | Drug | GW642444H 100mcg |
| placeboplacebo | Other | Placebo |
Primary outcome
Adverse events
Time frame: throughout study
Laboratory safety tests
Time frame: throughout study
Holter monitoring
Time frame: throughout study
Vital signs and 12-lead ECG)
Time frame: throughout study
Mean change from baseline FEV1 24 hours after dosing.
Time frame: Day 1, on 5 separate occasions
Supine systolic and diastolic blood pressure and supine heart rate
Time frame: Day 1 on 5 separate occasions
QTc(B)and QTc(F)
Time frame: Day 1 on 5 separate occasions
5 secondary outcomes
Potassium Max decrease from baseline
Time frame: Day 1 on 5 separate occasions
Mean change from baseline(0-4h)potassium.
Time frame: Day 1 on 5 separate occasions
Glucose Max increase from baseline
Time frame: Day 1 on 5 separate occasions
Weighted mean change from baseline (0-4h)glucose
Time frame: Day 1 on 5 separate occasions
Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR
Time frame: Day 1 on 5 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 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
2 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 GW642444M and GW642444H in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 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 6 inclusion and 6 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 2 sites in Australia, New Zealand. 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?
Adverse events (time frame: throughout study). The study lists 7 primary outcomes in all. 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.