Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Key facts

Study ID

NCT01323621

Run by

GlaxoSmithKline

People needed

512

Starts

2011-03-18

Expected to finish

2012-01-24

Last updated by the study team

2018-02-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated written informed consent
• Male or females ≥ 40 years of age
• Established clinical history of COPD by ATS/ERS definition
• Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
• Former or current smoker > 10 pack years
• Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)

You may not qualify if…

• Current diagnosis of asthma
• Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
• Lung volume reduction surgery within previous 12 months
• Clinically significant abnormalities not due to COPD by chest x-ray
• Hospitalized for poorly controlled COPD within 12 weeks of Screening
• Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
• Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
• Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
• Carcinoma not in complete remission for at least 5 years
• Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
• Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation
• Known/suspected history of alcohol or drug abuse in the last 2 years
• Women who are pregnant or lactating or plan to become pregnant
• Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
• Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
• Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
• Non-compliance or inability to comply with study procedures or scheduled visits
• Affiliation with investigator site

Where it is running

• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Seneca, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Boerne, Texas, United States
• GSK Investigational Site — Lübeck, Schleswig-Holstein, Germany
• GSK Investigational Site — Naples, Campania, Italy
• GSK Investigational Site — San Felice A Cancello Caserta, Campania, Italy
• GSK Investigational Site — Telese Terme (BN), Campania, Italy
• GSK Investigational Site — Parma, Emilia-Romagna, Italy
• GSK Investigational Site — Rome, Lazio, Italy
• GSK Investigational Site — Rozzano (MI), Lombardy, Italy
• GSK Investigational Site — Cagliari, Sardinia, Italy
• GSK Investigational Site — Palermo, Sicily, Italy
• GSK Investigational Site — Torrette (AN), The Marches, Italy
• GSK Investigational Site — Florence, Tuscany, Italy
• GSK Investigational Site — Padova, Veneto, Italy
• GSK Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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