NCT01018186 is a Phase 3 clinical trial of Fluticasone Furoate/GW642444 in Asthma, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01018186?

NCT01018186 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01018186?

Interventions in NCT01018186: Fluticasone Furoate/GW642444, Fluticasone propionate.

Is NCT01018186 still recruiting?

NCT01018186 is currently completed. Last updated 15 February 2018.

Are results published for NCT01018186?

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

Last reviewed 2018-02-15 · How we verify

NCT01018186

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

Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study

Completed Phase 3 Results posted Last updated 15 February 2018

What this trial tests

Phase 3 trial testing Fluticasone Furoate/GW642444 in Asthma in 503 participants. Completed in 12 May 2011.

Timeline

19 October 2009

Primary endpoint
1 May 2011

12 May 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	503
Start date	19 October 2009
Primary completion	1 May 2011
Estimated completion	12 May 2011
Sites	47 locations across Thailand, United States, Germany, Ukraine

Drugs / interventions tested

Fluticasone Furoate/GW642444 — full drug profile →
Fluticasone propionate (FLUTICASONE PROPIONATE) — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

12 and older, any sex, with Asthma. 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.

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period Primary · From the start of study medication until Visit 11 (Week 52)/Early Withdrawal

An AE is defined as 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. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriat

Any AE

Group	Value	95% CI
FF/VI 100/25 µg OD	139
FF/VI 200/25 µg OD	134
FP 500 µg BID	73

Any SAE

Group	Value	95% CI
FF/VI 100/25 µg OD	3
FF/VI 200/25 µg OD	1
FP 500 µg BID	7

Number of Participants With Severe Asthma Exacerbations During the Treatment Period Primary · From the start of study medication until Visit 11 (Week 52)/Early Withdrawal

A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.

Group	Value	95% CI
FF/VI 100/25 µg OD	3
FF/VI 200/25 µg OD	6
FP 500 µg BID	3

Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Albumin, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	0.1	± 2.69
FF/VI 200/25 µg OD	0.2	± 2.87
FP 500 µg BID	-0.5	± 2.64

Albumin, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.2	± 2.68
FF/VI 200/25 µg OD	-0.3	± 2.79
FP 500 µg BID	-0.4	± 2.76

Albumin, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.1	± 2.81
FF/VI 200/25 µg OD	-0.8	± 2.72
FP 500 µg BID	-0.5	± 2.54

Total Protein, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.6	± 4.13
FF/VI 200/25 µg OD	-0.1	± 4.50
FP 500 µg BID	-0.6	± 3.96

Total Protein, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.1	± 3.90
FF/VI 200/25 µg OD	-1.0	± 4.47
FP 500 µg BID	-0.5	± 4.33

Total Protein, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.7	± 4.53
FF/VI 200/25 µg OD	-1.4	± 4.60
FP 500 µg BID	-1.0	± 4.38

Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

ALP, Week 12, n=158, 165, 84

Group	Value	95% CI
FF/VI 100/25 µg OD	-3.0	± 18.76
FF/VI 200/25 µg OD	-2.6	± 29.65
FP 500 µg BID	-4.7	± 24.47

ALP, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.0	± 32.68
FF/VI 200/25 µg OD	-5.8	± 30.56
FP 500 µg BID	-5.7	± 24.33

ALP, Week 52, n=157, 157, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-4.0	± 30.67
FF/VI 200/25 µg OD	-7.2	± 34.65
FP 500 µg BID	-9.3	± 27.54

ALT, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.0	± 10.43
FF/VI 200/25 µg OD	-0.2	± 13.51
FP 500 µg BID	-0.3	± 12.03

ALT, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.6	± 10.08
FF/VI 200/25 µg OD	-0.1	± 10.59
FP 500 µg BID	0.4	± 11.96

ALT, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.8	± 12.40
FF/VI 200/25 µg OD	-1.3	± 11.13
FP 500 µg BID	-0.1	± 9.78

AST, Week 12, n=171, 181, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.9	± 8.07
FF/VI 200/25 µg OD	-0.3	± 12.05
FP 500 µg BID	0.3	± 8.69

AST, Week 28, n=179, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.4	± 8.42
FF/VI 200/25 µg OD	-0.9	± 11.60
FP 500 µg BID	1.3	± 10.65

Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Direct bilirubin, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.3	± 0.99
FF/VI 200/25 µg OD	-0.3	± 0.98
FP 500 µg BID	-0.2	± 0.93

Direct bilirubin, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.3	± 0.97
FF/VI 200/25 µg OD	-0.2	± 1.01
FP 500 µg BID	-0.1	± 0.94

Direct bilirubin, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.4	± 0.99
FF/VI 200/25 µg OD	-0.4	± 1.00
FP 500 µg BID	-0.2	± 0.90

Indirect bilirubin, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.4	± 3.11
FF/VI 200/25 µg OD	-0.8	± 2.86
FP 500 µg BID	-0.6	± 3.04

Indirect bilirubin, Week 28, n=180, 175, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.3	± 3.09
FF/VI 200/25 µg OD	-0.9	± 2.87
FP 500 µg BID	-0.4	± 3.14

Indirect bilirubin, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-2.0	± 3.08
FF/VI 200/25 µg OD	-1.6	± 2.51
FP 500 µg BID	-0.8	± 2.68

Total Bilirubin, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.7	± 3.62
FF/VI 200/25 µg OD	-1.1	± 3.46
FP 500 µg BID	-0.8	± 3.44

Total Bilirubin, Week 28, n=180, 175, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.6	± 3.61
FF/VI 200/25 µg OD	-1.2	± 3.55
FP 500 µg BID	-0.5	± 3.46

Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Chloride, Week 12, n=172, 182, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.7	± 3.43
FF/VI 200/25 µg OD	-0.4	± 3.50
FP 500 µg BID	0.1	± 2.28

Chloride, Week 28, n=180, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.1	± 2.50
FF/VI 200/25 µg OD	0.2	± 2.73
FP 500 µg BID	-0.1	± 2.54

Chloride, Week 52, n=157, 159, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.5	± 2.51
FF/VI 200/25 µg OD	0.0	± 2.67
FP 500 µg BID	-0.3	± 2.31

CO2 content/bicarbonate, Week 12, n=171, 181, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.7	± 3.13
FF/VI 200/25 µg OD	-0.8	± 2.91
FP 500 µg BID	-0.2	± 2.72

CO2 content/bicarbonate, Week 28, n=179, 176, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	0.3	± 2.90
FF/VI 200/25 µg OD	0.1	± 2.61
FP 500 µg BID	0.9	± 2.60

CO2 content/bicarbonate, Week 52, n=156, 158, 67

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.1	± 2.53
FF/VI 200/25 µg OD	0.1	± 2.51
FP 500 µg BID	0.5	± 2.55

Glucose, Week 12, n=172, 181, 87

Group	Value	95% CI
FF/VI 100/25 µg OD	0.33	± 1.873
FF/VI 200/25 µg OD	0.17	± 2.085
FP 500 µg BID	0.10	± 1.233

Glucose, Week 28, n=180, 175, 79

Group	Value	95% CI
FF/VI 100/25 µg OD	0.21	± 1.547
FF/VI 200/25 µg OD	0.16	± 1.556
FP 500 µg BID	0.02	± 1.442

Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Basophils, Week 12, n=171, 170, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.01	± 0.330
FF/VI 200/25 µg OD	-0.06	± 0.331
FP 500 µg BID	-0.08	± 0.320

Basophils, Week 28, n=169, 169, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.01	± 0.319
FF/VI 200/25 µg OD	0.00	± 0.338
FP 500 µg BID	-0.06	± 0.310

Basophils, Week 52, n=155, 155, 71

Group	Value	95% CI
FF/VI 100/25 µg OD	0.02	± 0.314
FF/VI 200/25 µg OD	-0.03	± 0.279
FP 500 µg BID	-0.07	± 0.319

Eosinophils, Week 12, n=171, 170, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.35	± 4.048
FF/VI 200/25 µg OD	-0.88	± 3.825
FP 500 µg BID	-1.23	± 3.391

Eosinophils, Week 28, n=169, 169, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.97	± 3.991
FF/VI 200/25 µg OD	-1.34	± 3.774
FP 500 µg BID	-1.63	± 3.574

Eosinophils, Week 52, n=155, 155, 71

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.84	± 4.096
FF/VI 200/25 µg OD	-0.90	± 3.946
FP 500 µg BID	-1.19	± 3.611

Lymphocytes, Week 12, n=171, 170, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.57	± 9.280
FF/VI 200/25 µg OD	-0.91	± 8.414
FP 500 µg BID	-1.72	± 8.449

Lymphocytes, Week 28, n=169, 169, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.11	± 8.816
FF/VI 200/25 µg OD	-1.31	± 10.200
FP 500 µg BID	-1.66	± 11.054

Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Eosinophil count, Week 12, n=171, 170, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.010	± 0.3226
FF/VI 200/25 µg OD	-0.057	± 0.3841
FP 500 µg BID	-0.073	± 0.2220

Eosinophil count, Week 28, n=169, 169, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.039	± 0.3310
FF/VI 200/25 µg OD	-0.083	± 0.3698
FP 500 µg BID	-0.083	± 0.2363

Eosinophil count, Week 52, n=155, 155, 71

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.023	± 0.3273
FF/VI 200/25 µg OD	-0.037	± 0.3171
FP 500 µg BID	-0.044	± 0.2539

Total ANC, Week 12, n=171, 170, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	0.392	± 1.6161
FF/VI 200/25 µg OD	0.469	± 1.6904
FP 500 µg BID	0.493	± 1.7488

Total ANC, Week 28, n=169, 169, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	0.632	± 1.5922
FF/VI 200/25 µg OD	0.679	± 2.0157
FP 500 µg BID	0.750	± 2.0130

Total ANC, Week 52, n=136, 136, 60

Group	Value	95% CI
FF/VI 100/25 µg OD	0.524	± 1.4589
FF/VI 200/25 µg OD	0.612	± 1.9100
FP 500 µg BID	0.748	± 1.7946

Platelet Count, Week 12, n=167, 159, 78

Group	Value	95% CI
FF/VI 100/25 µg OD	-1.3	± 39.44
FF/VI 200/25 µg OD	1.5	± 68.10
FP 500 µg BID	1.5	± 43.26

Platelet Count, Week 28, n=164, 165, 74

Group	Value	95% CI
FF/VI 100/25 µg OD	1.0	± 44.49
FF/VI 200/25 µg OD	3.5	± 35.06
FP 500 µg BID	12.4	± 43.59

Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Week 12, n=176, 172, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.0073	± 0.02307
FF/VI 200/25 µg OD	-0.0013	± 0.02654
FP 500 µg BID	-0.0025	± 0.02318

Week 28, n=172, 170, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.0017	± 0.02213
FF/VI 200/25 µg OD	-0.0005	± 0.02464
FP 500 µg BID	-0.0028	± 0.02168

Week 52, n=157, 159, 72

Group	Value	95% CI
FF/VI 100/25 µg OD	-0.0027	± 0.02906
FF/VI 200/25 µg OD	-0.0021	± 0.02467
FP 500 µg BID	-0.0045	± 0.02495

Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.

Week 12, n=176, 172, 86

Group	Value	95% CI
FF/VI 100/25 µg OD	-3.4	± 7.48
FF/VI 200/25 µg OD	-1.8	± 8.25
FP 500 µg BID	-2.0	± 7.67

Week 28, n=172, 170, 77

Group	Value	95% CI
FF/VI 100/25 µg OD	-2.1	± 7.64
FF/VI 200/25 µg OD	-2.2	± 8.11
FP 500 µg BID	-2.4	± 7.72

Week 52, n=157, 159, 72

Group	Value	95% CI
FF/VI 100/25 µg OD	-2.6	± 10.26
FF/VI 200/25 µg OD	-2.9	± 7.47
FP 500 µg BID	-3.0	± 8.77

Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion Primary · Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the "To high and To low" categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value b

Week 12: To high, n=139, 140, 78

Group	Value	95% CI
FF/VI 100/25 µg OD	6	4.5 – 160.6
FF/VI 200/25 µg OD	7	5.9 – 491.8
FP 500 µg BID	2	5.3 – 780.5

Week 12: To normal or no change, n=139, 140, 78

Group	Value	95% CI
FF/VI 100/25 µg OD	131	5.7 – 547.4
FF/VI 200/25 µg OD	128	6.1 – 482.5
FP 500 µg BID	67	3.8 – 667.5

Week 12: To low, n=139, 140, 78

Group	Value	95% CI
FF/VI 100/25 µg OD	2	4.0 – 602.3
FF/VI 200/25 µg OD	5	10.4 – 549.6
FP 500 µg BID	9	3.4 – 396.4

Week 28: To high, n=135, 131, 59

Group	Value	95% CI
FF/VI 100/25 µg OD	8
FF/VI 200/25 µg OD	8
FP 500 µg BID	3

Week 28: To normal or no change, n=135, 131, 59

Group	Value	95% CI
FF/VI 100/25 µg OD	123
FF/VI 200/25 µg OD	120
FP 500 µg BID	47

Week 28: To low, n=135, 131, 59

Group	Value	95% CI
FF/VI 100/25 µg OD	4
FF/VI 200/25 µg OD	3
FP 500 µg BID	9

Week 52: To high, n=134, 140, 65

Group	Value	95% CI
FF/VI 100/25 µg OD	10
FF/VI 200/25 µg OD	7
FP 500 µg BID	4

Week 52: To normal or no change , n=134, 140, 65

Group	Value	95% CI
FF/VI 100/25 µg OD	119
FF/VI 200/25 µg OD	131
FP 500 µg BID	57

Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline Primary · Baseline and Week 12

A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.

Group	Value	95% CI
FF/VI 100/25 µg OD	1.03
FF/VI 200/25 µg OD	0.93
FP 500 µg BID	0.61

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 52 weeks of treatment).. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FF/VI 100/25 µg OD

Serious: 3/201 (1%)

Deaths: —

FF/VI 200/25 µg OD

Serious: 1/202 (0%)

Deaths: —

FP 500 µg BD

Serious: 7/100 (7%)

Deaths: —

Serious adverse events (9 terms)

Reaction	System	FF/VI 100/25 µg OD	FF/VI 200/25 µg OD	FP 500 µg BD
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Dengue Fever	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Pyelonephritis Acute	Infections and infestations	—	—	—
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Fibroadenoma of Breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Hepatitis	Hepatobiliary disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Deep Vein Thrombosis	Vascular disorders	—	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	FF/VI 100/25 µg OD	FF/VI 200/25 µg OD	FP 500 µg BD
Headache	Nervous system disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Extrasystoles	Cardiac disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Pyrexia	General disorders	—	—	—
Oral candidiasis	Infections and infestations	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Tension headache	Nervous system disorders	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—

Most-reported serious reactions: Asthma, Dengue Fever, Pneumonia, Pyelonephritis Acute, Breast Cancer, Fibroadenoma of Breast, Hepatitis, Myalgia.

Data from ClinicalTrials.gov NCT01018186 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444

Publications & conference data

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

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial.
Busse WW, O'Byrne PM, Bleecker ER, Lötvall J, et al · · 2013 · cited 55× · PMID 23440247 · DOI 10.1136/thoraxjnl-2012-202606
Vilanterol and fluticasone furoate for asthma.
Dwan K, Milan SJ, Bax L, Walters N, et al · · 2016 · cited 8× · PMID 27582089 · DOI 10.1002/14651858.cd010758.pub2
Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy.
Albertson TE, Bullick SW, Schivo M, Sutter ME. · · 2016 · cited 7× · PMID 28008228 · DOI 10.2147/dddt.s113573

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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 NCT01018186 (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: 15 February 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/NCT01018186.

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NCT01018186

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 (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Fluticasone Furoate/GW642444

Other recruiting trials for Asthma

Other GlaxoSmithKline trials

Verify against primary sources