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))

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01342913
First received: April 14, 2011
Last updated: August 21, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Onset on Treatment Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Trough FEV1 on Treatment Day 85 [ Time Frame: Baseline and Day 85 ] [ Designated as safety issue: No ]
    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.


Enrollment: 531
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342913

  Hide Study Locations
Locations
Belgium
GSK Investigational Site
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
France
GSK Investigational Site
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
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80809
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Delitzsch, Sachsen, Germany, 04509
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04207
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 10789
GSK Investigational Site
Hamburg, Germany, 20253
Italy
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Salerno, Campania, Italy, 84100
GSK Investigational Site
Roma, Lazio, Italy, 00135
GSK Investigational Site
Sesto S. Giovanni MI, Lombardia, Italy, 20099
GSK Investigational Site
Acquaviva Delle Fonti BA, Puglia, Italy, 70021
GSK Investigational Site
Pisa, Toscana, Italy, 56124
GSK Investigational Site
Perugia, Umbria, Italy, 06156
GSK Investigational Site
Cittadella PD, Veneto, Italy, 35013
GSK Investigational Site
Verona, Veneto, Italy, 37134
Philippines
GSK Investigational Site
Jaro, Iloilo City, Philippines, 5000
GSK Investigational Site
Lipa City, Philippines, 4217
GSK Investigational Site
Quezon City, Philippines, 1100
GSK Investigational Site
Quezon City, Philippines, 1101
Poland
GSK Investigational Site
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
Russian Federation
GSK Investigational Site
Chelyabinsk, Russian Federation, 454034
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Kemerovo, Russian Federation, 650099
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
Moscow, Russian Federation, 115093
GSK Investigational Site
Moscow, Russian Federation, 115446
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
Spain
GSK Investigational Site
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
Ukraine
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01342913     History of Changes
Other Study ID Numbers: 113107
Study First Received: April 14, 2011
Results First Received: May 30, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration
Europe: European Medicines Agency

Additional relevant MeSH terms:
Respiratory Aspiration
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 15, 2014