Phase 2
Completed N=20
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00519376 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period — 2; 1; 2; 0 Participants
Summary
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared in the form of a salt, and inactive ingredients (excipients) are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the 'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate (instead of cellobiose octaacetate). Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This study will be the first time the new 'M' salt form of the study drug will be given to COPD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period |
2; 1; 2; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period |
0.004; 0.001; 0.001; 0.004; -0.004; 0.003 | — |
| PRIMARY Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-0.4; -1.2; -0.5; -3.0; 0.8; -3.5 | — |
| PRIMARY Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-0.00714; -0.00065; 0.00208; 0.00905; 0.00094; 0.00 | — |
| PRIMARY Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period |
0.0044; -0.0024; -0.0018; -0.0161; 0.0036 | — |
| PRIMARY Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period |
0.6; -0.2; -0.2; -1.0; -0.5 | — |
| PRIMARY Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-0.11; -0.22; 0.24; 0.14; -0.21 | — |
| PRIMARY Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period |
0.1; -0.5; 1.1; -0.6; 1.0; 0.4 | — |
| PRIMARY Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-0.9; -0.1; -0.2; -0.9; 0.1; -1.7 | — |
| PRIMARY Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-0.085; 0.121; 0.032; -0.251; 0.082; 0.6 | — |
| PRIMARY Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period |
3.5; 4.9; 4.9; 1.0; 1.5; -1.1 | — |
| PRIMARY Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period |
-1.36; 0.20; -0.47; -0.76; -0.93 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period |
-1.1; -0.6; 1.5; 0.2; -5.2; -1.1 | — |
| PRIMARY Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period |
-2.9; 0.7; 0.1; 2.2; -2.4; 0.3 | — |
| PRIMARY Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period |
-7.3; -1.4; 1.0; 0.5; -8.9; -2.7 | — |
| SECONDARY Mean FEV1 Over 23 and 24 Hours After Dosing |
1.432; 1.622; 1.638; 1.642; 1.569 | — |
| SECONDARY Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) |
419.68; 419.56; 424.18; 422.36; 419.70; 439.37 | — |
| SECONDARY Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate |
71.12; 71.76; 71.57; 73.50; 71.22; 77.88 | — |
| SECONDARY Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure |
126.92; 126.28; 127.82; 128.99; 125.10; 133.23 | — |
| SECONDARY Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium |
5.94; 5.86; 5.95; 6.25; 5.71; 6.73 | — |
| SECONDARY AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 |
56.49; 222.36; 572.99; 98.13; 58.01; 106.31 | — |
| SECONDARY Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 |
78.16; 150.60; 259.96; 73.70; NA; NA | — |
| SECONDARY Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 |
0.175; 0.200; 0.425; 0.500; NA; 0.140 | — |
Eligibility Criteria
Inclusion criteria
- Male or female (of non-childbearing potential) > or = 40 years
- History of COPD
- Smoker or ex-smoker
- Body weight > or = 50 kg with BMI 18-32 kg/m2
Exclusion criteria
- History of significant disease
- Subjects with a primary asthma diagnosis
- Alpha-1 antitrypsin deficiency as underlying cause of COPD
- Recent respiratory tract infection
- Poorly controlled COPD
- Blood potassium level < 3.5mmol/L
- Short-term or long tern oxygen therapy
- Recent participation in another trial
- History of drug or alcohol abuse
- Known allergies
- Recent blood donation
- ECG abnormalities
Data sourced from ClinicalTrials.gov (NCT00519376). 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.