Who is sponsoring NCT00269087?

NCT00269087 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00269087?

Interventions in NCT00269087: fluticasone propionate/salmeterol combination DISKUS.

What condition does NCT00269087 study?

NCT00269087 studies Pulmonary Disease, Chronic Obstructive.

Is NCT00269087 still recruiting?

NCT00269087 is currently completed. Last updated 1 February 2019.

Are results published for NCT00269087?

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

Last reviewed 2019-02-01 · How we verify

NCT00269087

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

GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

Completed Phase 3 Results posted Last updated 1 February 2019

What this trial tests

Phase 3 trial testing fluticasone propionate/salmeterol combination DISKUS in Pulmonary Disease, Chronic Obstructive in 122 participants. Completed in 25 October 2006.

Timeline

28 January 2005

Primary endpoint
1 October 2006

25 October 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	28 January 2005
Primary completion	1 October 2006
Estimated completion	25 October 2006
Sites	5 locations across Japan

Drugs / interventions tested

fluticasone propionate/salmeterol combination DISKUS — full drug profile →

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.

Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) Primary · Up to Week 56

AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threate

Any AEs

Group	Value	95% CI
GW815SF 50/500 µg	120

Any SAEs

Group	Value	95% CI
GW815SF 50/500 µg	27

Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters Secondary · Up to Week 56

Hematology parameters: Red blood cells (RBC), Hemoglobin (Hb), Hematocrit, Platelet count (PC), White blood cells (WBC), Basophils, Eosinophils, Neutrophils, Lymphocytes and Monocytes were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with hematology values outside normal range were presented.

RBC, Baseline, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	30

RBC, Week 4, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	36

RBC, Week 12, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	36

RBC, Week 24, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	1

RBC, Week 24, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	21

RBC, Week 36, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	1

RBC, Week 36, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	22

RBC, Week 52/Withdrawal, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	1

Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters Secondary · Up to Week 56

Clinical chemistry parameters: Total bilirubin (TB), Alkaline phosphatase (Al-P), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Gamma-glutamyl transpeptidase (GTP), Lactate dehydrogenase (LDH), Total cholesterol (TC), Glucose, Creatinine, Blood urea nitrogen (BUN), Uric acid (UA), Sodium (Na), Potassium (K), Chloride (Cl) and Calcium (Ca) were presented as the outliers from the normal range as \> upper limit and \< lower limit. Only number of participants with clinical chemistry values outside normal range were presented.

TB, Baseline, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	1

TB, Week 4, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	2

TB, Week 12, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	3

TB, Week 12, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	1

TB, Week 24, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	5

TB, Week 36, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	2

TB, Week 36, < lower limit

Group	Value	95% CI
GW815SF 50/500 µg	1

TB, Week 52/ withdrawal, > upper limit

Group	Value	95% CI
GW815SF 50/500 µg	4

Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters Secondary · Up to Week 56

Urinalysis parameters: Urine protein, Glucose and Urobilinogen were presented as shift from Baseline. Only number of participants with urinalysis values more than Baseline values were presented. The plus sign increases with a higher level of glucose and proteins in the urine: 1+: slightly positive, 2+: positive, 3+: high positive and 4+: strongly positive.

Urine protein, Week 4, 1+ to 3+

Group	Value	95% CI
GW815SF 50/500 µg	1

Glucose, Week 4, 3+ to 4+

Group	Value	95% CI
GW815SF 50/500 µg	1

Urine protein, Week 12, 1+ to 2+

Group	Value	95% CI
GW815SF 50/500 µg	1

Urine protein, Week 12, 1+ to 3+

Group	Value	95% CI
GW815SF 50/500 µg	1

Glucose, Week 12, 2+ to 4+

Group	Value	95% CI
GW815SF 50/500 µg	1

Glucose, Week 12, 3+ to 4+

Group	Value	95% CI
GW815SF 50/500 µg	1

Urine protein, Week 24, 1+ to 2+

Group	Value	95% CI
GW815SF 50/500 µg	1

Urine protein, Week 24, 1+ to 3+

Group	Value	95% CI
GW815SF 50/500 µg	1

Mean Change From Baseline in Level of Plasma Cortisol 1 Secondary · Baseline and Week 24 and 52

On each assessment day at Week 24 and 52, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	0.86	± 2.945

Week 52/Withdrawal

Group	Value	95% CI
GW815SF 50/500 µg	-0.62	± 3.118

Mean Level of Plasma Cortisol 2 Secondary · Up to Week 56

On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry.

Baseline

Group	Value	95% CI
GW815SF 50/500 µg	9.41	± 26.69

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	10.08	± 34.19

Week 52/Withdrawal

Group	Value	95% CI
GW815SF 50/500 µg	8.49	± 38.63

Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Secondary · Baseline and up to Week 56

Systolic and diastolic BP was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

SBP, Week 4

Group	Value	95% CI
GW815SF 50/500 µg	0.5	± 14.22

SBP, Week 8

Group	Value	95% CI
GW815SF 50/500 µg	-0.1	± 14.74

SBP, Week 12

Group	Value	95% CI
GW815SF 50/500 µg	0.6	± 15.85

SBP, Week 16

Group	Value	95% CI
GW815SF 50/500 µg	0.7	± 15.98

SBP, Week 20

Group	Value	95% CI
GW815SF 50/500 µg	-0.8	± 17.08

SBP, Week 24

Group	Value	95% CI
GW815SF 50/500 µg	0.2	± 16.50

SBP, Week 28

Group	Value	95% CI
GW815SF 50/500 µg	-0.4	± 17.10

SBP, Week 32

Group	Value	95% CI
GW815SF 50/500 µg	-1.8	± 17.74

Mean Change From Baseline in Pulse Rate Secondary · Baseline and up to Week 56

Pulse rate was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.

Week 4

Group	Value	95% CI
GW815SF 50/500 µg	-1.5	± 11.19

Week 8

Group	Value	95% CI
GW815SF 50/500 µg	-1.6	± 10.12

Week 12

Group	Value	95% CI
GW815SF 50/500 µg	-0.4	± 10.40

Week 16

Group	Value	95% CI
GW815SF 50/500 µg	1.0	± 10.03

Week 20

Group	Value	95% CI
GW815SF 50/500 µg	1.1	± 11.19

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	1.4	± 11.74

Week 28

Group	Value	95% CI
GW815SF 50/500 µg	1.2	± 10.23

Week 32

Group	Value	95% CI
GW815SF 50/500 µg	0.4	± 10.69

Number of Participants With Abnormal Oropharyngeal Examination Findings Secondary · Up to Week 56

Oropharyngeal examination was performed in participants with suspected oral infection (candidiasis).

Week -2

Group	Value	95% CI
GW815SF 50/500 µg	1

Week 0

Group	Value	95% CI
GW815SF 50/500 µg	1

Week 4

Group	Value	95% CI
GW815SF 50/500 µg	3

Week 8

Group	Value	95% CI
GW815SF 50/500 µg	7

Week 12

Group	Value	95% CI
GW815SF 50/500 µg	7

Week 16

Group	Value	95% CI
GW815SF 50/500 µg	9

Week 20

Group	Value	95% CI
GW815SF 50/500 µg	9

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	9

Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings Secondary · Up to Week 56

On each assessment day at Week 24, 52 and follow up 12-lead ECG was performed. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance.

Baseline

Group	Value	95% CI
GW815SF 50/500 µg	2

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	3

Withdrawal

Group	Value	95% CI
GW815SF 50/500 µg	4

Mean Change From Baseline in Bone Mineral Density (BMD) Secondary · Baseline and up to Week 56

On each assessment day at Week 52 and follow up, lumber (L1-L4) BMD was determined with a BMD meter by the dual energy X-ray absorption (DEXA) method. Baseline value was the measurement taken during run-in period. Change from Baseline was any value post Baseline minus value at Baseline.

Group	Value	95% CI
GW815SF 50/500 µg	-0.014	± 0.0618

Mean Change From Baseline in Weight Secondary · Baseline and up to Week 56

Body weight was measured during run-in period, at Week 24 and 52.

Week 24

Group	Value	95% CI
GW815SF 50/500 µg	0.17	± 1.785

Withdrawal

Group	Value	95% CI
GW815SF 50/500 µg	-0.51	± 2.188

Adverse events — posted to ClinicalTrials.gov

Time frame: All on-treatment AEs and SAEs were assessed up to Week 56. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GW815SF 50/500 µg

Serious: 27/122 (22%)

Deaths: 2/122

Serious adverse events (21 terms)

Reaction	System	GW815SF 50/500 µg
Pneumonia	Infections and infestations	—
Chronic obstructive airways disease exacerbated	Respiratory, thoracic and mediastinal disorders	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—
Atypical mycobacterial infection	Infections and infestations	—
Influenza	Infections and infestations	—
Oesophageal candidiasis	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Nasal polyps	Respiratory, thoracic and mediastinal disorders	—
Colonic polyp	Gastrointestinal disorders	—
Gastric ulcer	Gastrointestinal disorders	—
Inguinal hernia	Gastrointestinal disorders	—
Reflux oesophagitis	Gastrointestinal disorders	—
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Vertigo positional	Ear and labyrinth disorders	—
Malaise	General disorders	—
Contusion	Injury, poisoning and procedural complications	—
Wound	Injury, poisoning and procedural complications	—
Diabetes mellitus	Metabolism and nutrition disorders	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—
Atherosclerosis obliterans	Vascular disorders	—

Other adverse events (12 terms — click to expand)

Reaction	System	GW815SF 50/500 µg
Nasopharyngitis	Infections and infestations	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—
Oral candidiasis	Infections and infestations	—
Chronic obstructive airways disease exacerbated	Respiratory, thoracic and mediastinal disorders	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—
Bronchitis acute	Infections and infestations	—
Pneumonia	Infections and infestations	—
Bronchitis	Infections and infestations	—
Constipation	Gastrointestinal disorders	—
Pharyngitis	Infections and infestations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Pneumonia, Chronic obstructive airways disease exacerbated, Pneumonia aspiration, Atypical mycobacterial infection, Influenza, Oesophageal candidiasis, Respiratory tract infection, Nasal polyps.

Data from ClinicalTrials.gov NCT00269087 adverse events section.

Sponsor's own description

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The distribution of blood eosinophil levels in a Japanese COPD clinical trial database and in the rest of the world.
Barnes N, Ishii T, Hizawa N, Midwinter D, et al · · 2018 · cited 10× · PMID 29440882 · DOI 10.2147/copd.s144108

Verify or expand the search:

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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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 NCT00269087 (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: 1 February 2019

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/NCT00269087.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00269087

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 (21 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Other GlaxoSmithKline trials

Verify against primary sources