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))

A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder 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 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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg; Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg

Detailed Description

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty 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.

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bouge, Belgium, 5004
    • GSK Investigational Site
  • Brussels, Belgium, 1200
    • GSK Investigational Site
  • Bruxelles, Belgium, 1070
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Genk, Belgium, 3600
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Gilly, Belgium, 6060
    • GSK Investigational Site
• France
  • Bethune Cedex, France, 62408
    • GSK Investigational Site
  • Brest Cedex, France, 29609
    • GSK Investigational Site
  • Lille, France, 59000
    • GSK Investigational Site
  • Marseille Cedex 20, France, 13915
    • GSK Investigational Site
  • Montpellier cedex 5, France, 34295
    • GSK Investigational Site
  • Nice, France, 06002
    • GSK Investigational Site
  • Pessac cedex, France, 33604
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 10789
    • GSK Investigational Site
  • Hamburg, Germany, 20253
    • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 80809
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
    • Frankfurt am Main, Hessen, Germany, 60596
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • GSK Investigational Site
  • Sachsen
    • Delitzsch, Sachsen, Germany, 04509
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04207
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
• Italy
  • Campania
    • Benevento, Campania, Italy, 82100
      • GSK Investigational Site
    • Salerno, Campania, Italy, 84100
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00135
      • GSK Investigational Site
  • Lombardia
    • Sesto S. Giovanni MI, Lombardia, Italy, 20099
      • GSK Investigational Site
  • Puglia
    • Acquaviva Delle Fonti BA, Puglia, Italy, 70021
      • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • GSK Investigational Site
  • Veneto
    • Cittadella PD, Veneto, Italy, 35013
      • GSK Investigational Site
    • Verona, Veneto, Italy, 37134
      • GSK Investigational Site
• Philippines
  • Jaro, Iloilo City, Philippines, 5000
    • GSK Investigational Site
  • Lipa City, Philippines, 4217
    • GSK Investigational Site
  • Quezon City, Philippines, 1101
    • GSK Investigational Site
  • Quezon City, Philippines, 1100
    • GSK Investigational Site
• Poland
  • Bialystok, Poland
    • GSK Investigational Site
  • Czestochowa, Poland, 42-200
    • GSK Investigational Site
  • Lodz, Poland, 93-329
    • GSK Investigational Site
  • Lodz, Poland, 92-107
    • GSK Investigational Site
  • Ostrow Wielkopolski, Poland, 63-400
    • GSK Investigational Site
  • Piekary Slaskie, Poland, 41-940
    • GSK Investigational Site
  • Wilkowice, Poland, 43-365
    • GSK Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454034
    • GSK Investigational Site
  • Kazan, Russian Federation, 420015
    • GSK Investigational Site
  • Kemerovo, Russian Federation, 650000
    • GSK Investigational Site
  • Moscow, Russian Federation, 115446
    • GSK Investigational Site
  • Moscow, Russian Federation, 125367
    • GSK Investigational Site
  • Moscow, Russian Federation, 115093
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150003
    • GSK Investigational Site
• Spain
  • Alicante, Spain, 03114
    • GSK Investigational Site
  • Barakaldo (Vizcaya), Spain, 48903
    • GSK Investigational Site
  • Cáceres, Spain, 10003
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Pozuelo De Alarcón/Madrid, Spain, 28223
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • Valencia, Spain, 46015
    • GSK Investigational Site
• Ukraine
  • Cherkassy, Ukraine, 18009
    • GSK Investigational Site
  • Ivano-Frankivsk, Ukraine, 76018
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61035
    • GSK Investigational Site
  • Kiev, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 04107
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluticasone Furoate/Vilanterol; Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)	Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg; Inhalation Powder
Active Comparator: Fluticasone Propionate/Salmeterol; Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA	Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg; Inhalation Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84	Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.	Baseline and Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Onset on Treatment Day 1	Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.	Day 1
Change From Baseline in Trough FEV1 on Treatment Day 85	Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.	Baseline and Day 85

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 19, 2011

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate
• Other Study ID Numbers: 113107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: 113107
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register