Adults 18 to 50, any sex, with Rhinitis, Allergic, Seasonal. 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.
Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene ExpressionPrimary· Day 1
The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4
CREM
Group
Value
95% CI
Placebo
2625.5
± 0.03
GSK256066 1 mcg
2987.2
± 0.03
GSK256066 10 mcg
3134.2
± 0.03
GSK256066 50 mcg
3162.0
± 0.03
GSK256066 200 mcg
3727.0
± 0.03
DUSP1
Group
Value
95% CI
Placebo
8771.4
± 0.04
GSK256066 1 mcg
12718.0
± 0.04
GSK256066 10 mcg
13569.4
± 0.04
GSK256066 50 mcg
15221.2
± 0.04
GSK256066 200 mcg
15310.1
± 0.04
FOSL2
Group
Value
95% CI
Placebo
10550.0
± 0.03
GSK256066 1 mcg
15672.4
± 0.03
GSK256066 10 mcg
16039.4
± 0.03
GSK256066 50 mcg
17776.4
± 0.03
GSK256066 200 mcg
16374.4
± 0.03
IRS2
Group
Value
95% CI
Placebo
3260.5
± 0.05
GSK256066 1 mcg
5052.0
± 0.05
GSK256066 10 mcg
5059.6
± 0.05
GSK256066 50 mcg
5671.2
± 0.05
GSK256066 200 mcg
5083.8
± 0.05
NR4A2
Group
Value
95% CI
Placebo
703.3
± 0.07
GSK256066 1 mcg
1081.0
± 0.07
GSK256066 10 mcg
1316.8
± 0.07
GSK256066 50 mcg
1522.5
± 0.07
GSK256066 200 mcg
1427.1
± 0.07
PDE4A
Group
Value
95% CI
Placebo
43.4
± 0.05
GSK256066 1 mcg
44.5
± 0.05
GSK256066 10 mcg
51.3
± 0.05
GSK256066 50 mcg
51.7
± 0.05
GSK256066 200 mcg
59.8
± 0.05
RGS1
Group
Value
95% CI
Placebo
509.5
± 0.06
GSK256066 1 mcg
542.2
± 0.06
GSK256066 10 mcg
617.6
± 0.06
GSK256066 50 mcg
698.4
± 0.06
GSK256066 200 mcg
697.3
± 0.06
SNF1LK
Group
Value
95% CI
Placebo
2502.7
± 0.05
GSK256066 1 mcg
6810.4
± 0.05
GSK256066 10 mcg
7608.3
± 0.05
GSK256066 50 mcg
8205.7
± 0.05
GSK256066 200 mcg
8317.7
± 0.05
Mean Forced Expiratory Volume in One Second (FEV1)Secondary· Up to 9 weeks
The FEV1 is the volume of air forcefully exhaled in 1 second. The highest FEV1 value amongst the three recorded FEV1 readings was used for all FEV1 calculations. FEV1 was recorded pre-dose and at follow-up.
Group
Value
95% CI
Placebo
4.073
± 0.9045
GSK256066 1 mcg
4.116
± 0.8506
GSK256066 10 mcg
4.018
± 0.8564
GSK256066 50 mcg
4.151
± 0.8726
GSK256066 200 mcg
4.096
± 0.8909
Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study PeriodSecondary· Up to 9 weeks
Vital signs included SBP and DBP. SBP and DBP were measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.
DBP
Group
Value
95% CI
Placebo
70.8
± 6.06
GSK256066 1 mcg
69.4
± 6.33
GSK256066 10 mcg
69.2
± 6.67
GSK256066 50 mcg
70.6
± 7.24
GSK256066 200 mcg
68.9
± 6.83
SBP
Group
Value
95% CI
Placebo
117.0
± 10.76
GSK256066 1 mcg
117.0
± 10.34
GSK256066 10 mcg
113.8
± 9.51
GSK256066 50 mcg
118.9
± 10.91
GSK256066 200 mcg
115.1
± 9.97
Mean Heart Rate Over Study PeriodSecondary· Up to 9 weeks
Vital signs included heart rate. Heart rate was measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.
Group
Value
95% CI
Placebo
58.8
± 9.47
GSK256066 1 mcg
59.7
± 9.10
GSK256066 10 mcg
57.9
± 9.16
GSK256066 50 mcg
60.5
± 12.34
GSK256066 200 mcg
57.8
± 10.84
Change From Baseline in Electrocardiogram (ECG) ValuesSecondary· Baseline (Day 1) to 9 weeks
Electrocardiogram variables evaluated included PR interval, QRS duration, QT interval, QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) and RR interval. ECG was performed pre-dose, one hour and four hour post-dose. The ECG measurements were made with the participant in a supine position having rested in this position for at least 10 minutes before each time-point. Baseline was defined as the pre-dose measurement on Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values
PR Interval, 1 hour post-dose
Group
Value
95% CI
Placebo
-1.10
± 6.650
GSK256066 1 mcg
-0.87
± 6.962
GSK256066 10 mcg
-0.13
± 9.157
GSK256066 50 mcg
1.73
± 8.132
GSK256066 200 mcg
1.81
± 8.553
PR Interval, 4 hour post-dose
Group
Value
95% CI
Placebo
-4.06
± 7.857
GSK256066 1 mcg
-5.87
± 11.374
GSK256066 10 mcg
-3.00
± 7.379
GSK256066 50 mcg
-2.40
± 10.081
GSK256066 200 mcg
-5.74
± 9.560
QRS Duration, 1 hour post-dose
Group
Value
95% CI
Placebo
-0.77
± 3.783
GSK256066 1 mcg
-0.27
± 2.449
GSK256066 10 mcg
-0.50
± 3.172
GSK256066 50 mcg
-1.40
± 2.931
GSK256066 200 mcg
0.06
± 4.049
QRS Duration, 4 hour post-dose
Group
Value
95% CI
Placebo
-0.97
± 3.996
GSK256066 1 mcg
-0.93
± 3.005
GSK256066 10 mcg
-1.06
± 3.835
GSK256066 50 mcg
-1.40
± 2.931
GSK256066 200 mcg
0.13
± 4.440
QT Interval, 1 hour post-dose
Group
Value
95% CI
Placebo
3.55
± 10.865
GSK256066 1 mcg
11.67
± 13.996
GSK256066 10 mcg
6.38
± 13.645
GSK256066 50 mcg
8.93
± 12.213
GSK256066 200 mcg
4.77
± 11.851
QT Interval, 4 hour post-dose
Group
Value
95% CI
Placebo
-17.29
± 16.113
GSK256066 1 mcg
-11.40
± 16.079
GSK256066 10 mcg
-13.88
± 12.638
GSK256066 50 mcg
-15.07
± 21.151
GSK256066 200 mcg
-16.52
± 18.147
QTcB, 1 hour post-dose
Group
Value
95% CI
Placebo
0.58
± 13.393
GSK256066 1 mcg
1.67
± 11.689
GSK256066 10 mcg
-2.94
± 9.277
GSK256066 50 mcg
1.23
± 14.555
GSK256066 200 mcg
1.03
± 14.061
QTcB, 4 hour post-dose
Group
Value
95% CI
Placebo
-2.32
± 14.063
GSK256066 1 mcg
0.30
± 18.646
GSK256066 10 mcg
-4.44
± 13.361
GSK256066 50 mcg
-1.27
± 15.726
GSK256066 200 mcg
-2.32
± 12.621
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)Secondary· Up to 9 weeks
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any
AE
Group
Value
95% CI
Placebo
7
GSK256066 1 mcg
6
GSK256066 10 mcg
6
GSK256066 50 mcg
8
GSK256066 200 mcg
10
SAE
Group
Value
95% CI
Placebo
0
GSK256066 1 mcg
0
GSK256066 10 mcg
0
GSK256066 50 mcg
0
GSK256066 200 mcg
0
Number of Participants With Hematology Values of Potential Clinical ConcernSecondary· Up to 9 weeks
Blood samples for hematology were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with hematology of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for white blood cell count (clinical concern range: 3 to 20 giga cells/liter), neutrophils (normal range: 2.1 to 10.0 giga cells/liter), hemoglobin (clinical concern upper value: \>180 grams/liter). Only those parameters for which at least o
Group
Value
95% CI
Overall Study
4
Number of Participants With Clinical Chemistry Values of Potential Clinical ConcernSecondary· Up to 9 weeks
Blood samples for clinical chemistry were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with clinical chemistry values of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for total bilirubin levels (clinical concern upper value: \>31 micromole/liter) and inorganic phosphorus level (normal range: 0.7-1.5 millimole/liter).
Group
Value
95% CI
Overall Study
4
Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066Secondary· Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
The pharmacokinetics (PK) of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the active investigational product provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066. AUC (0-last) was not calculable for any participant at 1 mcg GSK256066 dose.
Group
Value
95% CI
GSK256066 10 mcg
7.7
± 58
GSK256066 50 mcg
14.7
± 59
GSK256066 200 mcg
41.9
± 97
AUC (0-last) of Active Metabolite GSK614917Secondary· Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
The PK of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. AUC (0-last) was not calculable in any participant at the 1, 10 or 50 mcg GSK256066 dose.
Group
Value
95% CI
GSK256066 200 mcg
12.7
± 63.0
Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066Secondary· Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
The PK of GSK256066 were assessed in plasma by determining Cmax. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.
Group
Value
95% CI
GSK256066 1 mcg
6.3
± 198
GSK256066 10 mcg
5.1
± 110
GSK256066 50 mcg
5.9
± 70
GSK256066 200 mcg
20.4
± 121
Cmax of Active Metabolite GSK614917Secondary· Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
The PK of GSK614917 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. C max was not calculable for any participant at the 1 mcg GSK256066 dose.
Group
Value
95% CI
GSK256066 10 mcg
2.7
± 47.6
GSK256066 50 mcg
2.4
± 20.1
GSK256066 200 mcg
5.2
± 62.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 9 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic range.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00549744 — Clinical Endpoint Trial Investigating Once Daily and Bronchodilator Dosing
· Phase 2
· completed
NCT00549679 — Study To Evaluate Safety And Tolerability Of GSK256066 In Chronic Obstructive Pulmonary Disease (COPD) Patients
· Phase 2
· completed
NCT00515268 — Endotoxin Challenge Study For Healthy Men and Women
· Phase 1
· completed
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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: 20 August 2018
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/NCT00464568.