Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

NCT01627327 | Completed Phase 3 Results

• 1 other identifier: 115805
• Study Type: interventional
• Target: 623
• Locations: 6 countries
• Sites: 54

Brief Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Cardiovascular event; Cardiovascular disease

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), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 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 (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.

  Baseline and Day 84

Secondary Outcomes (2)

• Time to Onset on Treatment Day 1

  Baseline and Day 1

• Change From Baseline in Trough FEV1 at Treatment Day 84

  Baseline and Day 84

Study Arms (2)

fluticasone furoate/vilanterol

EXPERIMENTAL

inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)

Drug: fluticasone furoate/vilanterol 100/25mcg

tiotropium bromide

ACTIVE COMPARATOR

anticholinergic

Drug: tiotropium bromide 18mcg

Interventions

fluticasone furoate/vilanterol 100/25mcg DRUG

inhalation powder

fluticasone furoate/vilanterol

tiotropium bromide 18mcg DRUG

inhalation powder

Also known as: Spiriva

tiotropium bromide

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
• Females must be post-menopausal or using a highly effective method for avoidance of pregnancy
• Established clinical history of COPD by ATS/ERS definition
• Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)
• Former or current smoker ≥10 pack years
• A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:
• Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)
• Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)
• Previous stroke
• Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)
• Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):
• Current diagnosis of hypertension
• Current diagnosis of hypercholesterolemia
• Diabetes mellitus treated with pharmacotherapy

You may not qualify if:

• Current diagnosis of asthma
• Lung volume reduction surgery within previous 12 months
• Clinically significant abnormalities not due to COPD by chest X-ray or CT scan
• 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
• A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period
• An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization
• An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization
• An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)
• Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at \>60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction \<30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities
• Carcinoma not in complete remission for at least 5 years
• History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded
• Known/suspected history of alcohol or drug abuse in the last 2 years
• Women who are pregnant or lactating or plan to become pregnant

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (54)

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Medford, Oregon, 97404, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Seneca, South Carolina, 29678, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Winnipeg, Manitoba, R2H 2A6, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5V 2T3, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2W 1T8, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4N 3C5, Canada

Location

GSK Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

Location

GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Kralupy nad Vltavou, 278 01, Czechia

Location

GSK Investigational Site

Kroměříž, 767 55, Czechia

Location

GSK Investigational Site

Teplice, 415 10, Czechia

Location

GSK Investigational Site

Třebíč, 674 01, Czechia

Location

GSK Investigational Site

Žamberk, 564 01, Czechia

Location

GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

Location

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Neu-Isenburg, Hesse, 63263, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01069, Germany

Location

GSK Investigational Site

Leipzg, Saxony, 04109, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 10789, Germany

Location

GSK Investigational Site

Bialystok, Poland

Location

GSK Investigational Site

Częstochowa, 42-200, Poland

Location

GSK Investigational Site

Działdowo, 13-200, Poland

Location

GSK Investigational Site

Krakow, 31-024, Poland

Location

GSK Investigational Site

Piekary Śląskie, 41-940, Poland

Location

GSK Investigational Site

Słupsk, 76-200, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Bucharest, 020125, Romania

Location

GSK Investigational Site

Bucharest, 030317, Romania

Location

GSK Investigational Site

Bucharest, 050159, Romania

Location

GSK Investigational Site

Bucharest, 70000, Romania

Location

GSK Investigational Site

Cluj-Napoca, 400371, Romania

Location

GSK Investigational Site

Constanța, 900002, Romania

Location

GSK Investigational Site

Iași, 700115, Romania

Location

GSK Investigational Site

Suceava, 720284, Romania

Location

GSK Investigational Site

Timișoara, 300310, Romania

Location

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; Cardiovascular Diseases

Interventions

fluticasone furoate; vilanterol; Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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: June 21, 2012
• First Posted: June 25, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 21, 2012
• Last Updated: November 9, 2017
• Results First Posted: November 1, 2013

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (13); US (11); CA (9); CZ (5); PL (7); RO (9)