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/500mcg Fluticasone Propionate (FP))
NCT ID: NCT01342913
Last Updated: 2018-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
528 participants
INTERVENTIONAL
2011-02-01
2011-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder
Interventions
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Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Bouge, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Edegem, , Belgium
GSK Investigational Site
Genk, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Gilly, , Belgium
GSK Investigational Site
Béthune, , France
GSK Investigational Site
Brest, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Pessac, , France
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Delitzsch, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Acquaviva Delle Fonti BA, Apulia, Italy
GSK Investigational Site
Benevento, Campania, Italy
GSK Investigational Site
Salerno, Campania, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Sesto S. Giovanni MI, Lombardy, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Perugia, Umbria, Italy
GSK Investigational Site
Cittadella PD, Veneto, Italy
GSK Investigational Site
Verona, Veneto, Italy
GSK Investigational Site
Jaro, Iloilo City, , Philippines
GSK Investigational Site
Lipa City, , Philippines
GSK Investigational Site
Quezon City, , Philippines
GSK Investigational Site
Quezon City, , Philippines
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Częstochowa, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Ostrów Wielkopolski, , Poland
GSK Investigational Site
Piekary Śląskie, , Poland
GSK Investigational Site
Wilkowice, , Poland
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Kemerovo, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Alicante, , Spain
GSK Investigational Site
Barakaldo (Vizcaya), , Spain
GSK Investigational Site
Cáceres, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, , Spain
GSK Investigational Site
San Sebastián, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Cherkassy, , Ukraine
GSK Investigational Site
Ivano-Frankivsk, , Ukraine
GSK Investigational Site
Kharkiv, , Ukraine
GSK Investigational Site
Kiev, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
Countries
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References
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Agusti A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.
Study Documents
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Document Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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113107
Identifier Type: -
Identifier Source: org_study_id
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