Phase 3 N=122 Treatment

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

Pulmonary Disease, Chronic Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT00269087 ↗

Enrolled (actual)

122

Serious AEs

22.1%

Results posted

Feb 2019

Primary outcome: Primary: Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) — 120; 27 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: fluticasone propionate/salmeterol combination DISKUS (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)	120; 27	—
SECONDARY Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters	30; 36; 36; 1; 21; 1	—
SECONDARY Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters	1; 2; 3; 1; 5; 2	—
SECONDARY Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters	1; 1; 1; 1; 1; 1	—
SECONDARY Mean Change From Baseline in Level of Plasma Cortisol 1	0.86; -0.62	—
SECONDARY Mean Level of Plasma Cortisol 2	9.41; 10.08; 8.49	—
SECONDARY Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	0.5; -0.1; 0.6; 0.7; -0.8; 0.2	—
SECONDARY Mean Change From Baseline in Pulse Rate	-1.5; -1.6; -0.4; 1.0; 1.1; 1.4	—
SECONDARY Number of Participants With Abnormal Oropharyngeal Examination Findings	1; 1; 3; 7; 7; 9	—
SECONDARY Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings	2; 3; 4	—
SECONDARY Mean Change From Baseline in Bone Mineral Density (BMD)	-0.014	—
SECONDARY Mean Change From Baseline in Weight	0.17; -0.51	—
SECONDARY Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings	3; 2; 3; 4; 4; 4	—
SECONDARY Mean Change From Baseline in Peak Expiratory Flow (PEF)	0.315; 0.446; 0.394; 0.357; 0.309; 0.328	—
SECONDARY Mean Change From Baseline in Forced Vital Capacity (FVC)	0.128; 0.156; 0.142; 0.140; 0.106; 0.127	—
SECONDARY Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity	0.018; 0.021; 0.015; 0.016; 0.012; 0.017	—
SECONDARY Mean Change From Baseline in Percent of Days Without Use of Rescue Medication	15.6	—
SECONDARY Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings	-0.2; 0.0; 0.0; -0.1	—
SECONDARY Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations	0.456	—
SECONDARY Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP)	124.63	—
SECONDARY Mean Cmax of Salmeterol	66.04	—
SECONDARY Median Time of Observed Maximum Plasma Concentration (Tmax) of FP	0.875	—
SECONDARY Median Tmax of Salmeterol	0.250	—
SECONDARY Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP	903.48	—
SECONDARY Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol	158.16	—

Summary

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.

Eligibility Criteria

Inclusion criteria

Diagnosis of COPD.

Exclusion criteria

Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
Other inclusion and exclusion criteria will be evaluated at the first study visit.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00269087). 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.