Phase 3
Completed N=562
A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01316887 ↗
Enrolled (actual)
562
Serious AEs
6.8%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) — 57; 132; 120; 7 Participants
Summary
The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) |
57; 132; 120; 7; 17; 14 | — |
| SECONDARY Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period |
26; 33; 29 | — |
| SECONDARY Time to the First On-treatment COPD Exacerbation |
NA; NA; NA | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12 |
0.3; 0.8; 0.6; -1.3; 3.2; 1.0 | — |
| SECONDARY Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 |
-0.5; -0.8; -0.8; -0.6; -0.9; -0.4 | — |
| SECONDARY Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12 |
-0.004; -0.006; -0.016; -0.027; -0.011; 0.000 | — |
| SECONDARY Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 |
-3.20; -1.63; -0.51; -0.52; -1.14; 0.13 | — |
| SECONDARY Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 |
-0.02; 0.01; 0.02; -0.03; 0.03; 0.01 | — |
| SECONDARY Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 |
0.001; -0.002; -0.007; -0.005; -0.007; 0.015 | — |
| SECONDARY Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 |
-0.0140; -0.0134; -0.0131; -0.0195; -0.0177; -0.0170 | — |
| SECONDARY Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period |
14.5; 14.0; 13.5; -11.0; -9.5; -10.8 | — |
| SECONDARY Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period |
9.1; 9.8; 9.0 | — |
| SECONDARY Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week |
15.6; 16.9; 18.4; 17.1; 19.0; 20.7 | — |
| SECONDARY Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period |
7.8; 9.9; 9.3 | — |
| SECONDARY Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline |
32; 64; 71; 52; 105; 101 | — |
| SECONDARY Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation |
39; 86; 87; 46; 98; 110 | — |
| SECONDARY Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period |
-0.4; -0.8; -1.4 | — |
| SECONDARY Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period |
11.1; 13.1; 23.2 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12 |
-0.030; 0.138; 0.161; -0.036; 0.140; 0.189 | — |
Eligibility Criteria
Inclusion Criteria
- outpatient
- signed and dated written informed consent
- 40 years of age or older
- male and female subjects
- COPD diagnosis
- at least 10 pack-year smoking history
- post-albuterol/salbutamol FEV1/FVC ratio of 10000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
- initiation or discontinuation of ICS within 30 days of Visit 1
- use of tiotropium within 14 days of Visit 1
- use of roflumilast within 14 days of Visit 1
- use of theophyllines within 48 hours of Visit 1
- use of oral leukotriene inhibitors within 48 hours prior to Visit 1
- use of long-acting oral beta-agonists within 48 hours of Visit 1
- use of short-acting oral beta-agonists within 12 hours of Visit 1
- use of inhaled long-acting beta-agonists within 48 hours prior to Visit 1
- use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
- use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
- use of inhaled short acting beta-agonists within 4 hours of Visit 1
- use of inhaled short-acting anticholinergics within 4 hours of Visit 1
- use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours of Visit 1
- use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) of Visit 1
- long-term oxygen therapy prescribed for >12 hours per day
- regular use of short-acting bronchodilators
- use of CPAP or NIPPV
- participation in the maintenance phase of a pulmonary rehabilitation program
- known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1
- anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.)
- previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination
Data sourced from ClinicalTrials.gov (NCT01316887). 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.