Phase 2 Completed N=68 Randomized Double-blind Treatment

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

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT00372112 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Feb 2018

Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) — 4; 5; 7; 6 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)	4; 5; 7; 6; 0; 0	—
SECONDARY 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	4.60; 0.18; 0.17; 0.95; 1.13; -1.31	—
SECONDARY 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	2.14; 4.25; 7.47; 4.63; 1.01; 0.63	—
SECONDARY Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14	6.50; 3.07; 7.16; 6.47; 2.77; 1.84	—
SECONDARY 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	20.6; 22.7; 23.5; 20.5; 9.7; 11.9	—
SECONDARY 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	70.08; 72.23; 73.03; 77.50; 71.07; 68.24	—
SECONDARY Mean Hourly HR 0-24 h at Day 1, 7 and 14	68.20; 68.38; 72.51; 73.48; 68.84; 69.89	—
SECONDARY Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14	70.6; 71.1; 74.4; 76.6; 72.2; 72.8	—
SECONDARY Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time	-7.21; -4.54; -1.67; -6.55; -6.17; -4.15	—
SECONDARY Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time	11.2; 11.8; 14.5; 9.3; 2.8; 2.8	—
SECONDARY 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	130.55; 128.47; 130.66; 126.05; 128.15; 122.90	—
SECONDARY 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	2.548; 4.166; 4.557; -1.622; 2.445; -2.215	—
SECONDARY 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	396.518; 397.667; 391.300; 396.361; 398.828; 403.565	—
SECONDARY Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time	474.2567; 470.3755; 468.4990; 470.6075; 471.3443; 470.9166	—
SECONDARY Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time	107.2; 397.3; 134.9; 61.9; 0.0; 0.8	—
SECONDARY Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14	0; 0; 0; 1; 1; 0	—
SECONDARY Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14	0; 0; 1; 0; 0; 1	—
SECONDARY 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	-0.019; 0.139; 0.149; 0.181; -0.006; 0.155	—
SECONDARY Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time	1.6180; 1.5294; 2.0224; 1.6674; 1.6498; 1.5796	—
SECONDARY Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14	0.0191; 0.1322; 0.1781; 0.0955; -0.0174; 0.1568	—
SECONDARY Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time	268.20; 249.99; 276.45; 244.44; 271.37; 266.22	—
SECONDARY Mean Use of Rescue Medication Over Period	3.12; 2.46; 1.38; 1.66; 1.99; 1.63	—
SECONDARY Number of Participants With Rescue Free Days	10; 9; 5; 10; 0; 2	—
SECONDARY Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14	-0.22; 0.61; 0.11; 0.22; 0.08; 0.57	—
SECONDARY 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	0.048; 0.057; 0.285; 0.140; -0.137; 0.062	—
SECONDARY Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time	5.917; 5.202; 5.537; 5.744; 5.913; 5.237	—
SECONDARY AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14	151.067; NA; 164.374; NA; 166.055; NA	—
SECONDARY Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14	78.851; 226.407; 82.642; 427.282; 92.089; 308.546	—
SECONDARY Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14	1.000; 1.000; 1.000; 0.130; 0.555; 0.525	—
SECONDARY AUC (0-4) of CCI2189 at Day 1, 7 and 14	11.779; 45.664; 12.155; 52.866; 13.683; 48.348	—
SECONDARY Cmax of CCI2189 at Day 1, 7 and 14	4.692; 15.650; 4.578; 21.293; 5.115; 18.315	—
SECONDARY AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14	NA; NA; NA; NA; NA; NA	—
SECONDARY Cmax of GW630200 and GSK932009 at Day 1, 7 and 14	NA; NA; NA; NA; NA; NA	—
SECONDARY Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14	1.285; 1.000; 1.010; 1.000; 1.000; 1.000	—
SECONDARY AUC (0-4) of Salmeterol at Day 1, 7 and 14	225.334; 226.708; 178.656	—
SECONDARY Cmax of Salmeterol at Day 1, 7 and 14	50.218; 59.943; 51.983	—
SECONDARY Tmax of Salmeterol at Day 1, 7 and 14	1.000; 1.000; 1.000	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00372112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.