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)
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 2/17/2018 |
Start Date: | March 18, 2011 |
End Date: | January 24, 2012 |
A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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.
100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily
over a 12-week treatment period in subjects with COPD.
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.
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.
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
We found this trial at
14
sites
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