Study to Evaluate 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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg

Drug: Fluticasone Propionate 250mcg/ salmeterol 50mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01323634

113109

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Enrollment

519 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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