A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01053988

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1031 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-05
• Study Completion Date: 2011-04-14

Brief Summary

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FF/GW642444 Inhalation Powder

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

Group Type: EXPERIMENTAL

FF/GW642444 Inhalation Powder

Intervention Type: DRUG

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

FF Inhalation Powder

Inhaled Corticosteroid (ICS)

Group Type: EXPERIMENTAL

FF Inhalation Powder

Intervention Type: DRUG

Inhaled Corticosteroid (ICS)

GW642444 Inhalation Powder

Long Acting Beta Agonist(LABA)

Group Type: EXPERIMENTAL

GW642444 Inhalation Powder

Intervention Type: DRUG

Long Acting Beta Agonist(LABA)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

FF/GW642444 Inhalation Pwdr

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

Group Type: EXPERIMENTAL

FF/GW642444 Inhalation Powder

Intervention Type: DRUG

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

Interventions

FF/GW642444 Inhalation Powder

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

Intervention Type: DRUG

FF Inhalation Powder

Inhaled Corticosteroid (ICS)

Intervention Type: DRUG

GW642444 Inhalation Powder

Long Acting Beta Agonist(LABA)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

FF Inhalation Powder; Placebo; GW642444 Inhalation Powder

Eligibility Criteria

Inclusion Criteria

• Type of subject: outpatient
• Informed consent: Subjects must give their signed and dated written informed consent to participate.
• Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of:
• Non-child bearing potential OR
• Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
• Age: ≥40 years of age at Screening (Visit 1)
• COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
• Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
• Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
• FEV1/FVC ratio of ≤0.70 and
• FEV1 ≤70% of predicted normal values
• Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Asthma: Subjects with a current diagnosis of asthma
• α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
• Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
• Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
• Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
• Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
• Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
• Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
• Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
• Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
• Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
• Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
• Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medication or components of the inhalation powder
• Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
• Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit
• Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
• Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
• Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
• Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
• Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
• Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
• Prior use of study medication/other investigational drugs
• Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Montgomery, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Encinitas, California, United States

GSK Investigational Site

Rancho Mirage, California, United States

GSK Investigational Site

Riverside, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Sepulveda, California, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Maitland, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Panama City, Florida, United States

GSK Investigational Site

Tamarac, Florida, United States

GSK Investigational Site

Winter Park, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Austell, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

Evansville, Indiana, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Hazard, Kentucky, United States

GSK Investigational Site

Madisonville, Kentucky, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Fall River, Massachusetts, United States

GSK Investigational Site

Livonia, Michigan, United States

GSK Investigational Site

Edina, Minnesota, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Gaffney, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Pelzer, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Wichita Falls, Texas, United States

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Pärnu, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Deggingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwetzingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Aschaffenburg, Bavaria, Germany

GSK Investigational Site

Erlangen, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Rüdersdorf, Brandenburg, Germany

GSK Investigational Site

Eschwege, Hesse, Germany

GSK Investigational Site

Kassel, Hesse, Germany

GSK Investigational Site

Rüsselsheim am Main, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

GSK Investigational Site

Gelsenkirchen, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Görlitz, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Schmölln, Thuringia, Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Nagano, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Monterrey NL, Nuevo León, Mexico

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Iloilo City, , Philippines

GSK Investigational Site

Lipa City, , Philippines

GSK Investigational Site

Pasig, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Grudziądz, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Ostrów Wielkopolski, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Wilkowice, , Poland

GSK Investigational Site

Wodzisław Śląski, , Poland

GSK Investigational Site

Zabrze, , Poland

GSK Investigational Site

Barnaul, , Russia

GSK Investigational Site

Irkutsk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Pyatigorsk, , Russia

GSK Investigational Site

Samara, , Russia

GSK Investigational Site

Shakhty, Rostov Region, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Tyumen, , Russia

GSK Investigational Site

Ufa, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Bucheon-si, , South Korea

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Kangwon-do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Uijeongbu-si, Kyonggi-do, , South Korea

Countries

United States; Chile; Estonia; Germany; Japan; Mexico; Philippines; Poland; Russia; South Korea

References

Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 23.

Reference Type: BACKGROUND

PMID: 23352226 (View on PubMed)

Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2025 Jun 19. doi: 10.1002/psp4.70059. Online ahead of print.

Reference Type: DERIVED

PMID: 40536286 (View on PubMed)

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Reference Type: DERIVED

PMID: 24314123 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

112206

Identifier Type: -

Identifier Source: org_study_id