Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01054885

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-19
• Study Completion Date: 2011-02-08

Brief Summary

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject 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

Fluticasone Furoate Inhalation Powder

Inhaled Corticosteroid (ICS)

Group Type: EXPERIMENTAL

FF Inhalation Powder

Intervention Type: DRUG

Inhaled Corticosteroid (ICS)

FF Inhalation Pwdr

Inhaled Corticosteroid (ICS)

Group Type: EXPERIMENTAL

FF Inhalation Powder

Intervention Type: DRUG

Inhaled Corticosteroid (ICS)

Fluticasone Furoate/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/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

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

Interventions

FF Inhalation Powder

Inhaled Corticosteroid (ICS)

Intervention Type: DRUG

FF/GW642444 Inhalation Powder

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

Intervention Type: DRUG

GW642444 Inhalation Powder

Long Acting Beta Agonist(LABA)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

Birmingham, Alabama, United States

GSK Investigational Site

Jasper, Alabama, United States

GSK Investigational Site

Lakewood, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Monterey Park, California, United States

GSK Investigational Site

National City, California, United States

GSK Investigational Site

Oxnard, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Wilmington, Delaware, United States

GSK Investigational Site

Bay Pines, Florida, United States

GSK Investigational Site

Brandon, Florida, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Cocoa, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Gainesville, Georgia, United States

GSK Investigational Site

Martinez, Georgia, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Wheaton, Maryland, United States

GSK Investigational Site

Saint Charles, Missouri, United States

GSK Investigational Site

Cherry Hill, New Jersey, United States

GSK Investigational Site

Ocean City, New Jersey, United States

GSK Investigational Site

Brooklyn, New York, United States

GSK Investigational Site

Elizabeth City, North Carolina, United States

GSK Investigational Site

Statesville, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Columbia, South Carolina, United States

GSK Investigational Site

Easley, South Carolina, United States

GSK Investigational Site

Gaffney, South Carolina, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Seneca, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Union, South Carolina, United States

GSK Investigational Site

Johnson City, Tennessee, United States

GSK Investigational Site

New Tazewell, Tennessee, United States

GSK Investigational Site

Boerne, Texas, United States

GSK Investigational Site

Corsicana, Texas, United States

GSK Investigational Site

Kingwood, Texas, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Fredericksburg, Virginia, United States

GSK Investigational Site

Morgantown, West Virginia, United States

GSK Investigational Site

Cipolletti, Río Negro Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Kralupy nad Vltavou, , Czechia

GSK Investigational Site

Liberec, , Czechia

GSK Investigational Site

Ostrava - Poruba, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Rokycany, , Czechia

GSK Investigational Site

Tábor, , Czechia

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Darmstadt, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Gelnhausen, Hesse, Germany

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Radebeul, Saxony, Germany

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Chiba, , Japan

GSK Investigational Site

Ehime, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Mie, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Częstochowa, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Gidle, , Poland

GSK Investigational Site

Giżycko, , Poland

GSK Investigational Site

Piekary Śląskie, , Poland

GSK Investigational Site

Szczecin, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Łomża, , Poland

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Constanța, , Romania

GSK Investigational Site

Deva, , Romania

GSK Investigational Site

Iași, , Romania

GSK Investigational Site

Popeşti-Leordeni, , Romania

GSK Investigational Site

Suceava, , Romania

GSK Investigational Site

Timișoara, , Romania

GSK Investigational Site

Chelyabinsk, , Russia

GSK Investigational Site

Ivanovo, , Russia

GSK Investigational Site

Kazan', , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Krasnoyarsk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Dnipropetrovsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Simferopol, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

Countries

United States; Argentina; Czechia; Germany; Japan; Poland; Romania; Russia; Ukraine

References

Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PM. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial. Respir Med. 2013 Apr;107(4):550-9. doi: 10.1016/j.rmed.2012.12.016. Epub 2013 Jan 16.

Reference Type: BACKGROUND

PMID: 23332861 (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: Dataset Specification

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

View Document

Document Type: Individual Participant Data Set

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: Clinical Study Report

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: Informed Consent Form

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

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Other Identifiers

112207

Identifier Type: -

Identifier Source: org_study_id