Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02105974

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-07
• Study Completion Date: 2015-07-08

Brief Summary

This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second [FEV1]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

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

Study Groups

Fluticasone Furoate/Vilanterol 100/25 Inhalation Powder

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

Group Type: EXPERIMENTAL

Fluticasone Furoate/Vilanterol

Intervention Type: DRUG

100 mcg FF micronized drug blended with lactose per blister in one strip and 25 mcg VI micronized drug blended with lactose and magnesium stearate per blister in another strip, administered together by ELLIPTA™ inhaler

Vilanterol 25 Inhalation Powder

Long-acting beta2-agonist (LABA)

Group Type: EXPERIMENTAL

Vilanterol

Intervention Type: DRUG

25 mcg of Vilanterol micronized drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister in one strip and lactose in another strip, administered together by ELLIPTA™ inhaler

Interventions

Fluticasone Furoate/Vilanterol

100 mcg FF micronized drug blended with lactose per blister in one strip and 25 mcg VI micronized drug blended with lactose and magnesium stearate per blister in another strip, administered together by ELLIPTA™ inhaler

Intervention Type: DRUG

Vilanterol

25 mcg of Vilanterol micronized drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister in one strip and lactose in another strip, administered together by ELLIPTA™ inhaler

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 subjects or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
• 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: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it is also associated with significant systemic consequences.
• Severity of disease: Subjects with a measured post-albuterol (salbutamol) FEV1/ Forced Vital Capacity (FVC) ratio of <=0.70 and FEV1 >=30 to <=70 percent of predicted normal values using Global Lung Function Initiative 2012 reference equations at Screening (Visit 1).
• Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
• History of COPD exacerbation: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Screening (Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or hospitalization.
• Current symptoms of COPD: A Subject Diary combined symptom score (combination of breathlessness, cough, sputum, and night time awakenings requiring treatment with albuterol [salbutamol]) of >=4 on at least 5 of the 7 days immediately preceding Visit 2 (Randomization)
• QTc Criteria: QTc <450 msec or QTc <480 msec for patients with bundle branch block.

Exclusion Criteria

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
• Other respiratory disorders: Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary 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 computed tomography [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. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 1 year prior to Screening (Visit 1).
• Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks following the last dose of systemic corticosteroids.
• Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening (Visit 1): Acute worsening of COPD that is managed by subject with systemic 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 Screening (Visit 1).
• COPD exacerbation/lower respiratory tract infection during the Run-In Period: Subjects who experience a moderate/severe COPD exacerbation (As per definition of "COPD Exacerbations and Pneumonia" in protocol) and/or a lower respiratory tract infection (including pneumonia) during the Run-In Period.
• Abnormal, clinically significant laboratory finding: Subjects who have an abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1) or upon repeat prior to randomization.
• Abnormal, clinically significant 12-lead ECG at Screening (Visit 1): Subjects who have an abnormal, clinically significant 12-Lead electrocardiogram (ECG) finding at Screening (Visit 1) or upon repeat prior to randomization.
• Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., patients requiring implantable cardioverter-defibrillators (ICD), pacemaker requiring a rate set >60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV, known left ventricular ejection fraction <30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities.
• Liver disease: Subjects who have unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Subjects with chronic stable hepatitis B and C are eligible if the subject otherwise meets entry criteria (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening). However, subjects with chronic stable hepatitis B are excluded if significant immunosuppressive or cytotoxic agents are administered, due to risk of hepatitis B reactivation, unless the hepatitis B antivirals are administered as outlined in the Chronic Hepatitis B American Association for the Study of Liver Diseases' (AASLD) Practice Guidelines.
• 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.
• Contraindications: Subjects with a history of allergy or hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroids) or components of the inhalation powder (e.g., lactose, magnesium stearate). 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.
• 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) or their ipratropium bromide for the 4-hour period required prior to spirometry testing at each study visit.
• Additional medication: 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)"
• Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen as needed (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).
• 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. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
• Non-Compliance during Run-In Period: Failure to demonstrate adequate compliance defined as completion of Diary Card (completed all diary entries on at least 5 of the last 7 consecutive days), the ability to withhold anti-COPD medications and to keep clinic visit appointments. In addition, subjects must have recorded the Run-In study medication use on at least 5 of the last 7, consecutive days of the Run-In period to continue in the study.
• Potential of 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: Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer. Note: Subjects who participated in a previously completed study and/or were excluded/ withdrawn from an ongoing study that included/includes FF/VI and/or VI are eligible to participate in the current study, if they have not received investigational study medication within 30 days of Screening (Visit 1).
• 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

Riverside, California, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Saint Charles, Missouri, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

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Medford, Oregon, United States

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Erie, Pennsylvania, United States

GSK Investigational Site

Easley, South Carolina, United States

GSK Investigational Site

Gaffney, South Carolina, United States

GSK Investigational Site

Greenville, 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

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

GSK Investigational Site

Morgantown, West Virginia, United States

GSK Investigational Site

Dimitrovgrad, , Bulgaria

GSK Investigational Site

Pleven, , Bulgaria

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Plovdiv, , Bulgaria

GSK Investigational Site

Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

GSK Investigational Site

Vidin, , Bulgaria

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Aschaffenburg, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Rüdersdorf, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

GSK Investigational Site

Osnabrück, Lower Saxony, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Delitzsch, Saxony, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Ehime, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

GSK Investigational Site

Ibaraki, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

GSK Investigational Site

Ishikawa, , Japan

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Ishikawa, , Japan

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Ishikawa, , Japan

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Ishikawa, , Japan

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Ishikawa, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Mie, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Niigata, , Japan

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Numakunai, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

GSK Investigational Site

Ōita, , Japan

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Ōita, , Japan

GSK Investigational Site

Saitama, , Japan

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Shizuoka, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

GSK Investigational Site

Toyama, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Toyama, , Japan

GSK Investigational Site

Yamaguchi, , Japan

GSK Investigational Site

Bialystok, , Poland

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Gdynia, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

GSK Investigational Site

Skierniewice, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

GSK Investigational Site

Bacau, , Romania

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Brăila, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Comuna Alexandru Cel Bun, , Romania

GSK Investigational Site

Craiova, , Romania

GSK Investigational Site

Iași, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Suceava, , Romania

GSK Investigational Site

Chelyabinsk, , Russia

GSK Investigational Site

Izhevsk, , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Khantymansiysk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

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Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petesburg, , Russia

GSK Investigational Site

Port Elizabeth, Eastern Cape, South Africa

GSK Investigational Site

Welkom, Free State, South Africa

GSK Investigational Site

Meyerspark, Gauteng, South Africa

GSK Investigational Site

Pretoria, Gauteng, South Africa

GSK Investigational Site

Bellville, , South Africa

GSK Investigational Site

Bloemfontein, , South Africa

GSK Investigational Site

Cape Town, , South Africa

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Durban, , South Africa

GSK Investigational Site

Gatesville, , South Africa

GSK Investigational Site

Mowbray, , South Africa

GSK Investigational Site

Tygerberg, , South Africa

GSK Investigational Site

Bucheon-si, , South Korea

GSK Investigational Site

Daegu, , 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

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Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Keelung, , Taiwan

GSK Investigational Site

New Taipei City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Dnipropetrovsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kremenchuk, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Mykolayiv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Germany; Japan; Poland; Romania; Russia; South Africa; South Korea; Taiwan; Ukraine

References

Siler TM, Nagai A, Scott-Wilson CA, Midwinter DA, Crim C. A randomised, phase III trial of once-daily fluticasone furoate/vilanterol 100/25 mug versus once-daily vilanterol 25 mug to evaluate the contribution on lung function of fluticasone furoate in the combination in patients with COPD. Respir Med. 2017 Feb;123:8-17. doi: 10.1016/j.rmed.2016.12.001. Epub 2016 Dec 2.

Reference Type: DERIVED

PMID: 28137501 (View on PubMed)

Study Documents

Document Type: Annotated Case Report 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: 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: 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

Related Links

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Other Identifiers

200820

Identifier Type: -

Identifier Source: org_study_id