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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00372112
Registration number
NCT00372112
Ethics application status
Date submitted
4/09/2006
Date registered
6/09/2006
Titles & IDs
Public title
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific 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
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Secondary ID [1]
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B2C108562
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW642444
Other interventions - Placebo
Active comparator: 100 mcg GW642444H - Twice daily in the morning.
Active comparator: 400 mcg GW642444H - Twice daily in the morning.
Active comparator: 50 mcg salmeterol - Twice daily.
Placebo comparator: placebo - Twice daily
Treatment: Drugs: GW642444
GW642444H
Other interventions: Placebo
Placebo administered twice daily
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
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Timepoint [1]
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Up to Follow-up (17 days)
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Secondary outcome [1]
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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
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Assessment method [1]
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HR was measured using 28.5h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the area under curve (AUC) of measurements made pre-dose on each day, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the average AUC minus Baseline (AAUCMB).
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Timepoint [1]
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Baseline (Day 1, pre-dose) up to Day 14
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Secondary outcome [2]
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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
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Assessment method [2]
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HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15 and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.
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Timepoint [2]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [3]
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Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14
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Assessment method [3]
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HR was measured using 28.5 h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-24 h post-dose on Day 7 and 14, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.
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Timepoint [3]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [4]
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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
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Assessment method [4]
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HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). For the calculation of 0-4 h maximum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1. Maximum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1) from the maximum assessment value (during 0-4 h) of the individual post-Baseline time points.
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Timepoint [4]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [5]
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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
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Assessment method [5]
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HR was measured using 28.5 h ABPM. Weighted mean HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Weighted mean HR at 0-24 h was obtained from measurements made 0-24 h post-dose on Day 1, 7 and 14. Maximum HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.
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Timepoint [5]
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Day 1 up to Day 15
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Secondary outcome [6]
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Mean Hourly HR 0-24 h at Day 1, 7 and 14
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Assessment method [6]
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HR was measured using 28.5 h ABPM. The assessments were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.
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Timepoint [6]
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Day 1 up to Day 14
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Secondary outcome [7]
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Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14
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Assessment method [7]
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HR was measured using 28.5 h ABPM. The assessments for maximum HR were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.
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Timepoint [7]
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Day 1 up to Day 14
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Secondary outcome [8]
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Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time
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Assessment method [8]
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BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the weighted mean SBP and DBP on pre-dose Day 1. The weighted mean change from Baseline was the AAUCMB. Data is reported for change from Baseline in weighted mean pre-dose values at Day 7 and Day 14; change from Baseline in weighted mean over 0-4 h at Day 1, 2, 7, 8, 14 and 15; and change from Baseline in weighted mean over 0-24 h at Day 1, 7 and 14.
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Timepoint [8]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [9]
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Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time
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Assessment method [9]
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BP was measured using 28.5 h ABPM. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. For the calculation of 0-4 h maximum/minimum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1 for SBP and DBP. Maximum/minimum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1 for SBP and DBP) from the maximum/minimum assessment value (during 0-4 h) of the individual post-Baseline time points.
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Timepoint [9]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [10]
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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
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Assessment method [10]
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BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.
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Timepoint [10]
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Day 1 up to Day 15
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Secondary outcome [11]
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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
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Assessment method [11]
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A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The Baseline for pre-dose QTcF and QTcB measurements was the pre-dose assessment on Day 1. Weighted mean at 0-4 h for QTcF and QTcB was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. The change from Baseline in maximum QTcF and QTcB at 0-4 h was calculated by subtracting the Baseline (pre-dose Day 1) value from the individual post-Baseline values.
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Timepoint [11]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [12]
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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
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Assessment method [12]
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A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The pre-dose QTcF and QTcB assessment was done at Day 1, 7 and 14. Weighted mean at 0-4 h for QTcF and QTcB at Day 1, 2, 7, 8, 14 and 15 was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The maximum QTcF and QTcB at 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.
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Timepoint [12]
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Day 1 up to Day 15
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Secondary outcome [13]
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Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time
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Assessment method [13]
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A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the ECG intervals. The assesmment for hourly maximums QTcF and QTcB was done on Day 1, Day 7 and Day 14. For each h of holter monitoring the maximum QTcF for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/3. For each h of holter monitoring the maximum QTcB for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)\^1/2.
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Timepoint [13]
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Day 1 up to Day 14
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Secondary outcome [14]
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Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time
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Assessment method [14]
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A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the heart's rhythm. The assessment for the events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h was done on Day 1, Day 7 and Day 14.
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Timepoint [14]
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Day 1 up to Day 14
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Secondary outcome [15]
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Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
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Assessment method [15]
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The parameters of biochemistry with their normal range included: alanine amino transferase (\[ALT\] 0-48 international units per liter \[IU/L\]), albumin (32-50 gram \[g\]/L), alkaline phosphatase (\[ALP\] 20-125 IU/L), aspartate amino transferase (\[AST\] 0-42 IU/L), calcium (2.12-2.56 millimole \[mmol\]/L, chloride (95-108 mmol/L), creatine kinase (\[CK\] 0-235 IU/L), creatinine (44-124 micromole \[µmol\]/L), direct bilirubin (0-6 µmol/L), gamma glutamyl transferase (\[GGT\] 0-65 IU/L), glucose (3.9-6.9 mmol/L), lactate dehydrogenase (\[LDH\] 0-250 IU/L), potassium (3.5-5.3 mmol/L), sodium (135-146 mmol/L), total bilirubin (0-22 µmol/L), total protein (60-85 g/L), urea (2.5-9 mmol/L) and uric acid (250-510 µmol/L). The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.
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Timepoint [15]
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Baseline (Day 1) up to Day 14
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Secondary outcome [16]
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Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14
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Assessment method [16]
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The parameters of biochemistry with their normal range included: basophils (0-0.2 giga cells \[GI\]/L), eosinophils (0.05-0.55 GI/L), haematocrit (0.41-0.5 ratio), hemoglobin (138-172 g/L), lymphocytes (0.85-4.1 GI/L), mean corpuscle hemoglobin (\[MCH\] 27-33 picogram \[pg\]), mean corpuscle hemoglobin concentration (\[MCHC\] 320-360 g/L), mean corpuscle volume (\[MCV\] 80-100 femtoliter \[fl\]), monocytes (0.2-1.1 GI/L), segmented neutrophils (1.8-8 GI/L), total neutrophils (1.8-8 GI/L), platelet count (130-400 GI/L), red blood cell (\[RBC\] 4.4-5.8 trillion cells \[TI\]/L) count and white blood cell (\[WBC\] 3.8-10.8 GI/L) count. The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.
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Timepoint [16]
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Baseline (Day 1) up to Day 14
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Secondary outcome [17]
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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
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Assessment method [17]
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FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose at Day 1, 2, 7, 8, 14 and 15. FEV1 was assessed post-dose at Day 1, 2, 7, 8 and 14. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Baseline was defined as the assessment done on pre-dose Day 1. The change from Baseline pre-dose was calculated by subtracting the Baseline value (pre-dose Day 1) from the individual post Baseline (Day 2, 7, 8, 14 and 15) values. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h change from Baseline was the AAUCMB obtained at Day 1, 2, 7, 8, 14 and 15. The maximum FEV1 0-4 h change from Baseline was obtained at Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15.
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Timepoint [17]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [18]
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Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time
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Assessment method [18]
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FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose and post-dose at Day 1, 2, 7, 8, 14 and 15. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h and maximum FEV1 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.
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Timepoint [18]
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Day 1 up to Day 15
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Secondary outcome [19]
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Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14
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Assessment method [19]
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FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 over 22-24 h was obtained at Day 1, Day 7 and Day 14 which was recorded up to Day 2, Day 8 and Day 15. Baseline was defined as the assessment on Day 1 pre-dose. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1, Day 7 and Day 14) values.
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Timepoint [19]
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Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [20]
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Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time
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Assessment method [20]
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PEF is a measure of lung function and measures how fast a person can breathe out. It was measured using a peak flow meter by the participants and recorded on daily record cards each day in the morning and evening from Screening up to Follow-up. The morning measurements were performed prior to the participant taking the morning dose of study medication or rescue medication. The evening measurements were performed prior to the participant taking the evening dose of study medication or rescue medication. The highest of the 3 values of morning and evening PEF were recorded on the diary card. The mean of 7 days of each morning and evening measurements were reported for the Run-in Week, Week 1, Week 2 and Follow-up.
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Timepoint [20]
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Up to Follow-up (Day 17)
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Secondary outcome [21]
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Mean Use of Rescue Medication Over Period
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Assessment method [21]
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Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The mean of 7 days (puffs per 24 h) were reported for the Run-in Week, Week 1, Week 2 and Follow-up.
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Timepoint [21]
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Up to Follow-up (Day 17)
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Secondary outcome [22]
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Number of Participants With Rescue Free Days
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Assessment method [22]
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Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The percentage of rescue free days during the Run-in week, Week 1, Week 2 and Follow-up Week were assessed. Data is reported for number of participants with \< 20%, \>=20 to \<40%, \>=40 to \<60%, \>=60 to \<80% and \>=80% rescue free days.
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Timepoint [22]
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Up to Follow-up (Day 17)
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Secondary outcome [23]
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Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14
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Assessment method [23]
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Blood samples were collected at pre-dose on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on pre-dose, Day 1. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 7 and Day 14) values.
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Timepoint [23]
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Baseline (Day 1, pre-dose) up to Day 14
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Secondary outcome [24]
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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
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Assessment method [24]
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Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the assessment on Day 1 pre-dose. The weighted mean change from Baseline was the AAUCMB. Change from Baseline in maximum glucose 0-4 h and minimum potassium 0-4 h was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1 to Day 15) values.
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Timepoint [24]
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0
Baseline (Day 1, pre-dose) up to Day 15
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Secondary outcome [25]
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Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time
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Assessment method [25]
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Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule.
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Timepoint [25]
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Day 1 up to Day 15
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Secondary outcome [26]
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AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14
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Assessment method [26]
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Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC over 4 h as AUC from zero (pre-dose) to 2 h post-dose (AUC \[0-2\]), AUC from zero (pre-dose) to 4 h post-dose (AUC \[0-4\]) and AUC from zero (pre-dose) to time of last quantifiable concentration (AUC \[0-t\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
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Timepoint [26]
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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)
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Secondary outcome [27]
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Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14
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Assessment method [27]
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Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
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Timepoint [27]
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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)
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Secondary outcome [28]
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Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14
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Assessment method [28]
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Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed and tlast was determined directly from the raw concentration-time data.
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Timepoint [28]
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0
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)
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Secondary outcome [29]
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0
AUC (0-4) of CCI2189 at Day 1, 7 and 14
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Assessment method [29]
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CCI2189 is a counterion of GW642444H. Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
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Timepoint [29]
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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)
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Secondary outcome [30]
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Cmax of CCI2189 at Day 1, 7 and 14
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Assessment method [30]
0
0
CCI2189 is a counterion of GW642444H. Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Query!
Timepoint [30]
0
0
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)
Query!
Secondary outcome [31]
0
0
AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14
Query!
Assessment method [31]
0
0
GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Query!
Timepoint [31]
0
0
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)
Query!
Secondary outcome [32]
0
0
Cmax of GW630200 and GSK932009 at Day 1, 7 and 14
Query!
Assessment method [32]
0
0
GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Query!
Timepoint [32]
0
0
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)
Query!
Secondary outcome [33]
0
0
Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14
Query!
Assessment method [33]
0
0
GW630200 and GSK932009 are metabolites of GW642444H. CCI2189 is a counterion of GW642444H. Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.
Query!
Timepoint [33]
0
0
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)
Query!
Secondary outcome [34]
0
0
AUC (0-4) of Salmeterol at Day 1, 7 and 14
Query!
Assessment method [34]
0
0
Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Query!
Timepoint [34]
0
0
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)
Query!
Secondary outcome [35]
0
0
Cmax of Salmeterol at Day 1, 7 and 14
Query!
Assessment method [35]
0
0
Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Query!
Timepoint [35]
0
0
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)
Query!
Secondary outcome [36]
0
0
Tmax of Salmeterol at Day 1, 7 and 14
Query!
Assessment method [36]
0
0
Blood samples were collected on 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). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.
Query!
Timepoint [36]
0
0
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)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
* females must be of non-childbearing potential
* moderately severe COPD
Query!
Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Query!
Query!
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
3/11/2006
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/05/2007
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
0
0
GSK Investigational Site - Camperdown
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Recruitment hospital [2]
0
0
GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
0
0
2050 - Camperdown
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Recruitment postcode(s) [2]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
Bulgaria
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State/province [1]
0
0
Ruse
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Country [2]
0
0
Bulgaria
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State/province [2]
0
0
Sofia
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Country [3]
0
0
Germany
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State/province [3]
0
0
Baden-Wuerttemberg
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Country [4]
0
0
Germany
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State/province [4]
0
0
Niedersachsen
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Country [5]
0
0
Germany
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State/province [5]
0
0
Schleswig-Holstein
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Country [6]
0
0
Netherlands
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State/province [6]
0
0
Breda
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Country [7]
0
0
Netherlands
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State/province [7]
0
0
Hoorn
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Country [8]
0
0
New Zealand
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State/province [8]
0
0
Auckland
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Country [9]
0
0
New Zealand
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State/province [9]
0
0
Tauranga
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Country [10]
0
0
Romania
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State/province [10]
0
0
Bucharest
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Country [11]
0
0
Romania
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State/province [11]
0
0
Iasi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/study/NCT00372112
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
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Address
0
0
GlaxoSmithKline
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
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Fax
0
0
Query!
Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00372112