NCT02522299 is a Phase 2 clinical trial of GSK2269557 in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02522299?

NCT02522299 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02522299?

Interventions in NCT02522299: GSK2269557, Placebo, DISKUS, ELLIPTA.

What condition does NCT02522299 study?

NCT02522299 studies Pulmonary Disease, Chronic Obstructive.

Is NCT02522299 still recruiting?

NCT02522299 is currently completed. Last updated 5 September 2021.

Are results published for NCT02522299?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-05 · How we verify

NCT02522299

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation

Completed Phase 2 Results posted Last updated 5 September 2021

What this trial tests

Phase 2 trial testing GSK2269557 in Pulmonary Disease, Chronic Obstructive in 44 participants. Completed in 22 June 2018.

Timeline

4 November 2015

Primary endpoint
15 June 2018

22 June 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	4 November 2015
Primary completion	15 June 2018
Estimated completion	22 June 2018
Sites	6 locations across Denmark, Canada

Drugs / interventions tested

GSK2269557 — full drug profile →
Placebo
DISKUS
ELLIPTA

Conditions studied

Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group Primary · Baseline (Screening) and Days 12, 28 and 84

Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted t

Day 12,222834_s_at, GNG12

Group	Value	95% CI
All NEMI	1.78

Day 12,210390_s_at, CCL15

Group	Value	95% CI
All NEMI	1.72

Day 12,212294_at, GNG12

Group	Value	95% CI
All NEMI	1.67

Day 12,226497_s_at, FLT1

Group	Value	95% CI
All NEMI	1.57

Day 12, 204356_at, LIMK1

Group	Value	95% CI
All NEMI	1.54

Day 12, 203923_s_at, CYBB

Group	Value	95% CI
All NEMI	1.51

Day 12, 219748_at, TREML2

Group	Value	95% CI
All NEMI	-1.51

Day 12, 1555086_at, STAT5B

Group	Value	95% CI
All NEMI	-1.51

Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group Primary · Baseline (Screening) and Days 12, 28 and 84

Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted t

Day 12, 222834_s_at, GNG12

Group	Value	95% CI
All Placebo	2.29

Day 12, 207852_at, CXCL5

Group	Value	95% CI
All Placebo	1.81

Day 12, 212294_at, GNG12

Group	Value	95% CI
All Placebo	1.79

Day 12, 209576_at, GNAI1

Group	Value	95% CI
All Placebo	1.61

Day 12, 213281_at, JUN

Group	Value	95% CI
All Placebo	1.51

Day 12, 222880_at, AKT3

Group	Value	95% CI
All Placebo	1.51

Day 12, 205026_at, STAT5B

Group	Value	95% CI
All Placebo	-1.50

Day 12, 201783_s_at, RELA

Group	Value	95% CI
All Placebo	-1.50

Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group Primary · Baseline (Screening) and Days 12, 28 and 84

Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment\*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All

Day 12,200671_s_at,SPTBN1

Group	Value	95% CI
All NEMI/All Placebo	-1.74

Day 12,226342_at,SPTBN1

Group	Value	95% CI
All NEMI/All Placebo	-1.89

Day 12,200672_x_at,SPTBN1

Group	Value	95% CI
All NEMI/All Placebo	-1.60

Day 12,209576_at,GNAI1

Group	Value	95% CI
All NEMI/All Placebo	-1.62

Day 12,202178_at,PRKCZ

Group	Value	95% CI
All NEMI/All Placebo	-1.55

Day 28,244313_at,CR1

Group	Value	95% CI
All NEMI/All Placebo	2.75

Day 28,223750_s_at,TLR10

Group	Value	95% CI
All NEMI/All Placebo	2.66

Day 28,217552_x_at,CR1

Group	Value	95% CI
All NEMI/All Placebo	2.25

Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes Secondary · Baseline (Screening), Days 12 and 28

siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the B

FRC,Scan Trimmed,Right Upper,Day 12,n=17,16

Group	Value	95% CI
All Placebo	1.020	0.854 – 1.217
All NEMI	1.038	0.880 – 1.225

FRC,Scan Trimmed,Right Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	1.027	0.838 – 1.258
All NEMI	1.030	0.924 – 1.147

FRC,Scan Trimmed,Left Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.970	0.798 – 1.180
All NEMI	0.993	0.857 – 1.151

FRC,Scan Trimmed,Left Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.008	0.779 – 1.304
All NEMI	1.053	0.937 – 1.184

FRC,Scan Trimmed,Right Middle,Day 12,n=17,16

Group	Value	95% CI
All Placebo	1.294	0.904 – 1.852
All NEMI	1.008	0.856 – 1.188

FRC,Scan Trimmed,Right Middle,Day 28,n=16,18

Group	Value	95% CI
All Placebo	1.071	0.773 – 1.484
All NEMI	0.973	0.865 – 1.093

FRC,Scan Trimmed,Right Lower,Day 12,n=17,17

Group	Value	95% CI
All Placebo	1.025	0.873 – 1.204
All NEMI	1.029	0.858 – 1.236

FRC,Scan Trimmed,Right Lower,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.032	0.872 – 1.222
All NEMI	1.042	0.924 – 1.174

Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 Secondary · Baseline (Day 12) and Day 28

siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan

FRC,Scan Trimmed,Right Upper,Day 28,n=16,17

Group	Value	95% CI
All Placebo	0.998	0.917 – 1.086
All NEMI	0.988	0.909 – 1.074

FRC,Scan Trimmed,Left Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.987	0.905 – 1.077
All NEMI	1.014	0.904 – 1.137

FRC,Scan Trimmed,Right Middle,Day 28,n=16,17

Group	Value	95% CI
All Placebo	1.003	0.876 – 1.149
All NEMI	0.930	0.828 – 1.043

FRC,Scan Trimmed,Right Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.938	0.845 – 1.041
All NEMI	1.020	0.884 – 1.176

FRC,Scan Trimmed,Left Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.947	0.849 – 1.057
All NEMI	1.042	0.905 – 1.200

TLC, Scan Trimmed,Right Upper,Day 28,n=17,18

Group	Value	95% CI
All Placebo	0.963	0.875 – 1.061
All NEMI	0.965	0.928 – 1.004

TLC, Scan Trimmed,Left Upper,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.984	0.896 – 1.079
All NEMI	0.999	0.940 – 1.061

TLC, Scan Trimmed,Right Middle,Day 28,n=17,18

Group	Value	95% CI
All Placebo	0.807	0.601 – 1.084
All NEMI	0.897	0.829 – 0.971

Change From Baseline in siVaw at FRC and TLC for Individual Regions Secondary · Baseline (Screening), Days 12 and 28

FRC,Scan Trimmed,Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.996	0.840 – 1.180
All NEMI	1.024	0.888 – 1.181

FRC,Scan Trimmed,Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.011	0.814 – 1.257
All NEMI	1.029	0.934 – 1.133

FRC,Scan Trimmed,Lower,Day 12,n=17,17

Group	Value	95% CI
All Placebo	1.003	0.881 – 1.143
All NEMI	1.039	0.901 – 1.199

FRC,Scan Trimmed,Lower,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.991	0.873 – 1.125
All NEMI	1.041	0.942 – 1.150

FRC,Scan Trimmed,Central,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.027	0.917 – 1.151
All NEMI	1.052	0.998 – 1.108

FRC,Scan Trimmed,Central,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.048	0.928 – 1.183
All NEMI	1.045	0.996 – 1.096

FRC,Scan Trimmed,Distal,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.970	0.859 – 1.096
All NEMI	1.029	0.891 – 1.187

FRC,Scan Trimmed,Distal,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.980	0.844 – 1.138
All NEMI	1.037	0.945 – 1.138

Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 Secondary · Baseline (Day 12) and Day 28

FRC,Scan Trimmed,Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.996	0.917 – 1.082
All NEMI	0.986	0.907 – 1.072

FRC,Scan Trimmed,Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.948	0.862 – 1.042
All NEMI	1.025	0.909 – 1.155

FRC,Scan Trimmed,Central,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.997	0.955 – 1.042
All NEMI	1.014	0.955 – 1.076

FRC,Scan Trimmed,Distal,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.977	0.898 – 1.063
All NEMI	0.996	0.914 – 1.085

FRC,Scan Trimmed,Total,Day 28,n=16, 18

Group	Value	95% CI
All Placebo	0.997	0.952 – 1.043
All NEMI	1.012	0.953 – 1.075

TLC,Scan Trimmed,Upper,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.973	0.884 – 1.070
All NEMI	0.970	0.930 – 1.012

TLC,Scan Trimmed,Lower,Day 28,n=17, 19

Group	Value	95% CI
All Placebo	0.954	0.865 – 1.051
All NEMI	0.952	0.893 – 1.014

TLC,Scan Trimmed,Central,Day 28,n=17,19

Group	Value	95% CI
All Placebo	1.009	0.979 – 1.040
All NEMI	0.977	0.943 – 1.012

Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes Secondary · Baseline (Screening) and Days 12 and 28

iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline valu

FRC,Scan Trimmed,Right Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.007	0.847 – 1.197
All NEMI	1.044	0.879 – 1.240

FRC,Scan Trimmed,Right Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.016	0.826 – 1.249
All NEMI	1.037	0.931 – 1.155

FRC,Scan Trimmed,Left Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.965	0.783 – 1.190
All NEMI	0.987	0.830 – 1.173

FRC,Scan Trimmed,Left Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.998	0.767 – 1.299
All NEMI	1.062	0.919 – 1.227

FRC,Right Middle,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.129	0.803 – 1.588
All NEMI	1.014	0.874 – 1.176

FRC,Scan Trimmed,Right Middle,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.950	0.739 – 1.221
All NEMI	1.018	0.881 – 1.176

FRC,Right Lower,Day 12,n=17,17

Group	Value	95% CI
All Placebo	1.046	0.884 – 1.237
All NEMI	1.005	0.824 – 1.225

FRC,Scan Trimmed,Right Lower,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.042	0.879 – 1.235
All NEMI	1.025	0.889 – 1.181

Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 Secondary · Baseline (Day 12) and Day 28

iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline

FRC,Scan Trimmed,Right Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.995	0.918 – 1.078
All NEMI	0.977	0.880 – 1.084

FRC,Scan Trimmed,Left Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.973	0.891 – 1.063
All NEMI	1.016	0.898 – 1.151

FRC,Scan Trimmed,Right Middle,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.958	0.842 – 1.090
All NEMI	0.943	0.838 – 1.061

FRC,Scan Trimmed,Right Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.918	0.821 – 1.025
All NEMI	1.008	0.855 – 1.188

FRC,Scan Trimmed,Left Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.943	0.852 – 1.045
All NEMI	1.024	0.877 – 1.196

TLC,Scan Trimmed,Right Upper,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.963	0.875 – 1.060
All NEMI	0.966	0.936 – 0.997

TLC,Scan Trimmed,Left Upper,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.976	0.885 – 1.076
All NEMI	0.996	0.942 – 1.052

TLC,Right Middle,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.784	0.571 – 1.077
All NEMI	0.904	0.841 – 0.971

Change From Baseline in iVaw at FRC and TLC for Individual Regions Secondary · Baseline (Screening) and Days 12 and 28

FRC,Scan Trimmed,Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.987	0.827 – 1.178
All NEMI	1.021	0.869 – 1.200

FRC,Scan Trimmed,Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.999	0.800 – 1.246
All NEMI	1.039	0.927 – 1.166

FRC,Scan Trimmed,Lower,Day 12,n=17,17

Group	Value	95% CI
All Placebo	1.009	0.864 – 1.178
All NEMI	1.017	0.863 – 1.199

FRC,Scan Trimmed,Lower,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.993	0.862 – 1.142
All NEMI	1.018	0.899 – 1.152

FRC,Scan Trimmed,Central,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.025	0.925 – 1.136
All NEMI	1.040	0.985 – 1.097

FRC,Scan Trimmed,Central,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.040	0.936 – 1.155
All NEMI	1.040	0.974 – 1.110

FRC,Scan Trimmed,Distal,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.969	0.847 – 1.107
All NEMI	1.017	0.866 – 1.194

FRC,Scan Trimmed,Distal,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.973	0.834 – 1.135
All NEMI	1.032	0.921 – 1.157

Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 Secondary · Baseline (Day 12) and Day 28

FRC,Scan Trimmed,Upper,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.988	0.912 – 1.070
All NEMI	0.985	0.891 – 1.089

FRC,Scan Trimmed,Lower,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.934	0.847 – 1.030
All NEMI	1.010	0.876 – 1.165

FRC,Scan Trimmed,Central,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.985	0.953 – 1.019
All NEMI	1.008	0.942 – 1.078

FRC,Scan Trimmed,Distal,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.966	0.891 – 1.047
All NEMI	0.990	0.890 – 1.102

FRC,Scan Trimmed,Total,Day 28,n=16,18

Group	Value	95% CI
All Placebo	0.985	0.949 – 1.022
All NEMI	1.006	0.938 – 1.080

TLC,Scan Trimmed,Upper,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.968	0.877 – 1.067
All NEMI	0.968	0.932 – 1.005

TLC,Scan Trimmed,Lower,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.933	0.840 – 1.037
All NEMI	0.942	0.879 – 1.010

TLC,Scan Trimmed,Central,Day 28,n=17,19

Group	Value	95% CI
All Placebo	0.996	0.968 – 1.024
All NEMI	0.972	0.940 – 1.004

Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes Secondary · Baseline (Screening) and Days 12 and 28

iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participan

FRC,Scan Trimmed,Right Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.129	0.641 – 1.991
All NEMI	0.876	0.477 – 1.606

FRC,Scan Trimmed,Right Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.213	0.569 – 2.586
All NEMI	0.884	0.582 – 1.343

FRC,Scan Trimmed,Left Upper,Day 12,n=18,17

Group	Value	95% CI
All Placebo	1.058	0.631 – 1.774
All NEMI	0.951	0.592 – 1.530

FRC,Scan Trimmed,Left Upper,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.151	0.582 – 2.273
All NEMI	0.681	0.438 – 1.060

FRC,Scan Trimmed,Right Middle,Day 12,n=18,17

Group	Value	95% CI
All Placebo	0.559	0.198 – 1.576
All NEMI	0.970	0.578 – 1.627

FRC,Scan Trimmed,Right Middle,Day 28,n=16,19

Group	Value	95% CI
All Placebo	1.420	0.573 – 3.518
All NEMI	1.275	0.732 – 2.219

FRC,Scan Trimmed,Right Lower,Day 12,n=17,17

Group	Value	95% CI
All Placebo	0.903	0.352 – 2.314
All NEMI	1.149	0.714 – 1.849

FRC,Scan Trimmed,Right Lower,Day 28,n=16,19

Group	Value	95% CI
All Placebo	0.681	0.251 – 1.850
All NEMI	0.935	0.512 – 1.706

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Via DISKUS

Serious: 2/14 (14%)

Deaths: 0/14

NEMI 1000 mcg Via DISKUS

Serious: 3/14 (21%)

Deaths: 0/14

Placebo Via ELLIPTA

Serious: 4/8 (50%)

Deaths: 0/8

NEMI 700 mcg Via ELLIPTA

Serious: 0/8 (0%)

Deaths: 0/8

Serious adverse events (10 terms)

Reaction	System	Placebo Via DISKUS	NEMI 1000 mcg Via DISKUS	Placebo Via ELLIPTA	NEMI 700 mcg Via ELLIPTA
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Laryngospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Oxygen saturation decreased	Investigations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—

Other adverse events (50 terms — click to expand)

Reaction	System	Placebo Via DISKUS	NEMI 1000 mcg Via DISKUS	Placebo Via ELLIPTA	NEMI 700 mcg Via ELLIPTA
Headache	Nervous system disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—
Periorbital cellulitis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Aphonia	Nervous system disorders	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Drug intolerance	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—
Anxiety disorder	Psychiatric disorders	—	—	—	—
Depressive symptom	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: Chronic obstructive pulmonary disease, Pneumonia, Bronchospasm, Laryngospasm, Pulmonary oedema, Coronary artery disease, Oxygen saturation decreased, Back pain.

Data from ClinicalTrials.gov NCT02522299 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate specific alterations in immune cell mechanisms related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment with GSK2269557 will also be measured using functional respiratory imaging (FRI) and spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to 84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14 weeks including the screening visit. DISKUS TM and ELLIPTA TM are registered trademark of GSK group of companies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Progress in the mechanism and targeted drug therapy for COPD.
Wang C, Zhou J, Wang J, Li S, et al · · 2020 · cited 214× · PMID 33110061 · DOI 10.1038/s41392-020-00345-x
Pathological Mechanism and Targeted Drugs of COPD.
Guo P, Li R, Piao TH, Wang CL, et al · · 2022 · cited 102× · PMID 35855746 · DOI 10.2147/copd.s366126
Emerging pharmaceutical therapies for COPD.
Lakshmi SP, Reddy AT, Reddy RC. · · 2017 · cited 35× · PMID 28790817 · DOI 10.2147/copd.s121416
Inhaled RNA Therapeutics for Obstructive Airway Diseases: Recent Advances and Future Prospects.
Xu Y, Thakur A, Zhang Y, Foged C. · · 2021 · cited 24× · PMID 33525500 · DOI 10.3390/pharmaceutics13020177
Targets of Neutrophil Influx and Weaponry: Therapeutic Opportunities for Chronic Obstructive Airway Disease.
Mårdh CK, Root J, Uddin M, Stenvall K, et al · · 2017 · cited 22× · PMID 28596972 · DOI 10.1155/2017/5273201
Defining Bronchial Asthma with Phosphoinositide 3-Kinase Delta Activation: Towards Endotype-Driven Management.
Jeong JS, Kim JS, Kim SR, Lee YC. · · 2019 · cited 21× · PMID 31323822 · DOI 10.3390/ijms20143525
Exploring PI3Kδ Molecular Pathways in Stable COPD and Following an Acute Exacerbation, Two Randomized Controlled Trials.
Begg M, Hamblin JN, Jarvis E, Bradley G, et al · · 2021 · cited 16× · PMID 34113094 · DOI 10.2147/copd.s309303
The Molecular Blueprint for Chronic Obstructive Pulmonary Disease (COPD): A New Paradigm for Diagnosis and Therapeutics.
Shakeel I, Ashraf A, Afzal M, Sohal SS, et al · · 2023 · cited 10× · PMID 38155869 · DOI 10.1155/2023/2297559

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02522299 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 5 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02522299.

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NCT02522299

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK2269557

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Other GlaxoSmithKline trials

Verify against primary sources