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))

NCT01342913 | Completed Phase 3 Results

• 1 other identifier: 113107
• Study Type: interventional
• Target: 528
• Locations: 9 countries
• Sites: 66

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to Onset on Treatment Day 1

  Day 1

• Change From Baseline in Trough FEV1 on Treatment Day 85

  Baseline and Day 85

Study Arms (2)

Fluticasone Furoate/Vilanterol

EXPERIMENTAL

Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)

Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg

Fluticasone Propionate/Salmeterol

ACTIVE COMPARATOR

Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA

Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg

Interventions

Fluticasone Furoate 100mcg/Vilanterol 25mcg DRUG

Inhalation Powder

Fluticasone Furoate/Vilanterol

Fluticaosne Propionate 500mcg/Salmeterol 50mcg DRUG

Inhalation Powder

Fluticasone Propionate/Salmeterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (66)

GSK Investigational Site

Bouge, 5004, Belgium

Location

GSK Investigational Site

Brussels, 1070, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Genk, 3600, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Gilly, 6060, Belgium

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GSK Investigational Site

Béthune, 62408, France

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GSK Investigational Site

Brest, 29609, France

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GSK Investigational Site

Lille, 59000, France

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GSK Investigational Site

Marseille, 13915, France

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Nice, 06002, France

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GSK Investigational Site

Pessac, 33604, France

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GSK Investigational Site

Munich, Bavaria, 80809, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Delitzsch, Saxony, 04509, Germany

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GSK Investigational Site

Dresden, Saxony, 01307, Germany

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GSK Investigational Site

Leipzig, Saxony, 04207, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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GSK Investigational Site

Berlin, 10117, Germany

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GSK Investigational Site

Berlin, 10787, Germany

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GSK Investigational Site

Berlin, 10789, Germany

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GSK Investigational Site

Berlin, 14057, Germany

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GSK Investigational Site

Hamburg, 20253, Germany

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GSK Investigational Site

Acquaviva Delle Fonti BA, Apulia, 70021, Italy

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GSK Investigational Site

Benevento, Campania, 82100, Italy

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GSK Investigational Site

Salerno, Campania, 84100, Italy

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GSK Investigational Site

Rome, Lazio, 00135, Italy

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GSK Investigational Site

Sesto S. Giovanni MI, Lombardy, 20099, Italy

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GSK Investigational Site

Pisa, Tuscany, 56124, Italy

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GSK Investigational Site

Perugia, Umbria, 06156, Italy

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GSK Investigational Site

Cittadella PD, Veneto, 35013, Italy

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GSK Investigational Site

Verona, Veneto, 37134, Italy

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GSK Investigational Site

Jaro, Iloilo City, 5000, Philippines

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GSK Investigational Site

Lipa City, 4217, Philippines

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GSK Investigational Site

Quezon City, 1100, Philippines

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GSK Investigational Site

Quezon City, 1101, Philippines

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GSK Investigational Site

Bialystok, Poland

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GSK Investigational Site

Częstochowa, 42-200, Poland

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GSK Investigational Site

Lodz, 92-107, Poland

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GSK Investigational Site

Lodz, 93-329, Poland

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GSK Investigational Site

Ostrów Wielkopolski, 63-400, Poland

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GSK Investigational Site

Piekary Śląskie, 41-940, Poland

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GSK Investigational Site

Wilkowice, 43-365, Poland

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GSK Investigational Site

Chelyabinsk, 454034, Russia

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GSK Investigational Site

Kazan', 420015, Russia

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GSK Investigational Site

Kemerovo, 650000, Russia

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GSK Investigational Site

Moscow, 115093, Russia

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GSK Investigational Site

Moscow, 115446, Russia

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GSK Investigational Site

Moscow, 125367, Russia

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GSK Investigational Site

Yaroslavl, 150003, Russia

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GSK Investigational Site

Alicante, 03114, Spain

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GSK Investigational Site

Barakaldo (Vizcaya), 48903, Spain

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GSK Investigational Site

Cáceres, 10003, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28223, Spain

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GSK Investigational Site

San Sebastián, 20014, Spain

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GSK Investigational Site

Valencia, 46015, Spain

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GSK Investigational Site

Cherkassy, 18009, Ukraine

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GSK Investigational Site

Ivano-Frankivsk, 76018, Ukraine

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GSK Investigational Site

Kharkiv, 61035, Ukraine

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GSK Investigational Site

Kiev, 03680, Ukraine

Location

GSK Investigational Site

Kyiv, 04107, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 24114969 DERIVED

Related 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone furoate; vilanterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 27, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 19, 2011
• Last Updated: August 31, 2018
• Results First Posted: July 30, 2013

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (7); DE (13); IT (9); RU (7); ES (7); PH (4); UA (5); PL (7); FR (7)