Overview

A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol

Status:
Completed
Trial end date:
2011-10-19
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Salmeterol Xinafoate
Xhance
Criteria
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)

- have been hospitalised or have been treated with oral corticosteroids or antibiotics
for their COPD within the last 3 years prior to Screening (Visit 1)

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