Last updated: 11/04/2018 05:36:53

A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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GSK study ID
B2C108562
See study documents
Clinicaltrials.gov ID
NCT00372112
See results summary
EudraCT ID
2006-004033-15
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 2-wk study to evaluate the safety, tolerability,pharmacodynamics and pharmacokinetics of GW642444H(100 administered once daily in the morning via DISKUS™ dry-powder inhaler)compared with SEREVENT(salmeterol)(50mcg administered twice daily via DISKUS dry-powder inhaler)and placebo in subject w/COPD
Trial description: The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with any adverse event (AE) or serious adverse event (SAE)

Timeframe: Up to Follow-up (17 days)

Secondary outcomes:

Change from Baseline in pre-dose weighted mean heart rate (HR) derived from 28.5 hour (h) ambulatory blood pressure monitoring (ABPM) at Day 7 and 14

Timeframe: Baseline (Day 1, pre-dose) up to Day 14

Change from Baseline in 0-4 h weighted mean HR derived from 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Change from Baseline in 0-24 h weighted mean HR derived from 28.5 ABPM at Day 7 and 14

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Change from Baseline in maximum HR during 0-4 h derived from 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean weighted mean HR at 0-4 h, weighted mean HR at 0-24 h and maximum HR at 0-4 h derived from 28.5 h ABPM

Timeframe: Day 1 up to Day 15

Mean hourly HR 0-24 h at Day 1, 7 and 14

Timeframe: Day 1 up to Day 14

Mean maximum hourly HR 0-24 h at Day 1, 7 and 14

Timeframe: Day 1 up to Day 14

Change from Baseline in weighted mean systolic and diastolic blood pressure (SBP and DBP) derived from 28.5 h ABPM over time

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Change from Baseline in maximum SBP and minimum DBP derived from 28.5 h ABPM over time

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean weighted mean SBP and DBP at 0-4 h, weighted mean SBP and DBP at 0-24 h and maximum SBP and minimum DBP at 0-4 h derived from 28.5 h ABPM

Timeframe: Day 1 up to Day 15

Change from Baseline in QTc by Federicia’s method (F) and QTc Bazett’s method (B) values at pre-dose, weighted mean 0-4 h and maximum 0-4 h derived from 12-lead electrocardiogram (ECG) over time

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean QTcF and QTcB values at pre-dose, weighted mean 0-4 h and maximum 0-4 h derived from 12-lead ECG over time

Timeframe: Day 1 up to Day 15

Mean of hourly maximums QTcF and QTcB derived from 24 h 3-lead Holter ECG monitoring over time

Timeframe: Day 1 up to Day 14

Number of events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h derived from 3-lead holter ECG monitoring over time

Timeframe: Day 1 up to Day 14

Number of participants with biochemistry abnormal change from Baseline values relative to the normal range at Day 7 and 14

Timeframe: Baseline (Day 1) up to Day 14

Number of participants with hematology abnormal change from Baseline values relative to the normal range at Day 7 and 14

Timeframe: Baseline (Day 1) up to Day 14

Change from Baseline in forced expiratory volume in one second (FEV1) at pre-dose, weighted mean FEV1 at 0-4 h and maximum FEV1 0-4 h over time

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean FEV1 weighted mean FEV1 at 0-4 h and maximum FEV1 at 0-4 h over time

Timeframe: Day 1 up to Day 15

Change from Baseline in weighted mean FEV1 over 22- 24 h on Days 1, 7 and 14

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean morning and evening peak expiratory flow rate (PEFR) over time

Timeframe: Up to Follow-up (Day 17)

Mean use of rescue medication over period

Timeframe: Up to Follow-up (Day 17)

Number of participants with rescue free days

Timeframe: Up to Follow-up (Day 17)

Change from Baseline in pre-dose fasting glucose and potassium at Day 7 and 14

Timeframe: Baseline (Day 1, pre-dose) up to Day 14

Change from Baseline in weighted mean glucose and potassium 0-4 h, maximum glucose 0-4 h and minimum potassium 0-4 h over time

Timeframe: Baseline (Day 1, pre-dose) up to Day 15

Mean weighted mean 0-4 h of glucose and potassium, maximum glucose 0-4 h and minimum potassium 0-4 h over time

Timeframe: Day 1 up to Day 15

AUC of GW642444H over 0 to 4 h (AUC [0–4]) on Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Maximum concentration (Cmax) of GW642444H at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Time to maximum concentration (tmax) and time of last quantifiable concentration (tlast) of GW642444H at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

AUC (0-4) of CCI2189 at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Cmax of CCI2189 at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Cmax of GW630200 and GSK932009 at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Time to maximum concentration (tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

AUC (0-4) of salmeterol at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Cmax of Salmeterol at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Tmax of salmeterol at Day 1, 7 and 14

Timeframe: Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)

Interventions:
Drug: GW642444
Other: Placebo
Enrollment:
68
Observational study model:
Not applicable
Primary completion date:
2007-10-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Not applicable
Study date(s)
November 2006 to May 2007
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
  • females must be of non-childbearing potential
  • Subjects with a main diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
  • females must be of non-childbearing potential
  • moderately severe COPD
Exclusion criteria:
  • Subjects with a main diagnosis of asthma
  • subjects with poorly controlled COPD
  • subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
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Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
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Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
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Location
GSK Investigational Site
BREDA, Netherlands, 4819 EV
Status
Study Complete
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Location
GSK Investigational Site
Sofia, Bulgaria, 1606
Status
Study Complete
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Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
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Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
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Location
GSK Investigational Site
Sofia, Bulgaria, 1431
Status
Study Complete
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Location
GSK Investigational Site
Bucharest, Romania, 050159
Status
Study Complete
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Location
GSK Investigational Site
Tauranga, New Zealand
Status
Study Complete
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Location
GSK Investigational Site
Iasi, Romania, 700506
Status
Study Complete
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Location
GSK Investigational Site
Auckland, New Zealand, 1005
Status
Study Complete
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Location
GSK Investigational Site
Ruse, Bulgaria, 7000
Status
Study Complete
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Location
GSK Investigational Site
HOORN, Netherlands, 1624 NP
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2007-10-05
Actual study completion date
2007-10-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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