AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT02105974

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)

A Phase 3 study testing Fluticasone Furoate/Vilanterol and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 237 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Fluticasone Furoate/Vilanterol and Vilanterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,621 participants
Where
237 sitesin 11 countries
Study dates
7 Apr 2014to 8 Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

237 sites in 11 countries.

237 sites in 11 countries

Japan121 sites

  • GSK Investigational Site

    Aichi, 454-8502

  • GSK Investigational Site

    Aichi, 455-8510

  • GSK Investigational Site

    Aichi, 457-8511

  • GSK Investigational Site

    Aichi, 460-0001

  • GSK Investigational Site

    Aichi, 471-8513

  • GSK Investigational Site

    Aichi, 489-8642

  • GSK Investigational Site

    Chiba, 278-0004

  • GSK Investigational Site

    Chiba, 296-8602

  • GSK Investigational Site

    Ehime, 791-0281

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 802-0083

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukuoka, 815-8588

  • GSK Investigational Site

    Fukuoka, 816-0813

  • GSK Investigational Site

    Fukuoka, 820-8505

  • GSK Investigational Site

    Fukuoka, 832-0059

  • GSK Investigational Site

    Gifu, 500-8523

  • GSK Investigational Site

    Gifu, 500-8717

  • GSK Investigational Site

    Gifu, 506-8550

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Gunma, 372-0831

  • GSK Investigational Site

    Hiroshima, 722-8503

  • GSK Investigational Site

    Hiroshima, 732-0052

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hiroshima, 735-8585

  • GSK Investigational Site

    Hokkaido, 001-0901

  • GSK Investigational Site

    Hokkaido, 040-8611

  • GSK Investigational Site

    Hokkaido, 053-8506

  • GSK Investigational Site

    Hokkaido, 060-0033

  • GSK Investigational Site

    Hokkaido, 062-8618

  • GSK Investigational Site

    Hokkaido, 063-0005

  • GSK Investigational Site

    Hokkaido, 064-0801

  • GSK Investigational Site

    Hokkaido, 064-0915

  • GSK Investigational Site

    Hokkaido, 070-8644

  • GSK Investigational Site

    Hokkaido, 071-8132

  • GSK Investigational Site

    Hokkaido, 080-0013

  • GSK Investigational Site

    Hokkaido, 080-0805

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Hyōgo, 664-8540

  • GSK Investigational Site

    Hyōgo, 672-8064

  • GSK Investigational Site

    Hyōgo, 675-8611

  • GSK Investigational Site

    Hyōgo, 678-0239

  • GSK Investigational Site

    Ibaraki, 310-0015

  • GSK Investigational Site

    Ibaraki, 317-0077

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Ishikawa, 920-8530

  • GSK Investigational Site

    Ishikawa, 920-8610

  • GSK Investigational Site

    Ishikawa, 920-8650

  • GSK Investigational Site

    Ishikawa, 921-8105

  • GSK Investigational Site

    Ishikawa, 923-8560

  • GSK Investigational Site

    Kagawa, 760-0018

  • GSK Investigational Site

    Kagawa, 760-8538

  • GSK Investigational Site

    Kagawa, 761-8073

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Kanagawa, 232-0066

  • GSK Investigational Site

    Kanagawa, 239-0821

  • GSK Investigational Site

    Kanagawa, 251-8550

  • GSK Investigational Site

    Kanagawa, 254-8502

  • GSK Investigational Site

    Kochi, 780-8077

  • GSK Investigational Site

    Kochi, 783-8505

  • GSK Investigational Site

    Kumamoto, 861-1196

  • GSK Investigational Site

    Kumamoto, 862-0954

  • GSK Investigational Site

    Kyoto, 601-1495

  • GSK Investigational Site

    Kyoto, 601-8206

  • GSK Investigational Site

    Kyoto, 607-8062

  • GSK Investigational Site

    Kyoto, 612-0026

  • GSK Investigational Site

    Kyoto, 615-8087

  • GSK Investigational Site

    Mie, 514-1101

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Miyagi, 981-8563

  • GSK Investigational Site

    Miyagi, 983-8520

  • GSK Investigational Site

    Miyagi, 984-8560

  • GSK Investigational Site

    Miyagi, 986-8522

  • GSK Investigational Site

    Miyagi, 989-1253

  • GSK Investigational Site

    Nagano, 390-0872

  • GSK Investigational Site

    Niigata, 950-2085

  • GSK Investigational Site

    Numakunai, 024-8506

  • GSK Investigational Site

    Ōita, 870-0921

  • GSK Investigational Site

    Ōita, 876-0813

  • GSK Investigational Site

    Okayama, 702-8055

  • GSK Investigational Site

    Okayama, 711-0921

  • GSK Investigational Site

    Okinawa, 901-0243

  • GSK Investigational Site

    Okinawa, 901-2121

  • GSK Investigational Site

    Okinawa, 901-2132

  • GSK Investigational Site

    Okinawa, 904-2143

  • GSK Investigational Site

    Okinawa, 904-2293

  • GSK Investigational Site

    Osaka, 530-0001

  • GSK Investigational Site

    Osaka, 530-8480

  • GSK Investigational Site

    Osaka, 533-0024

  • GSK Investigational Site

    Osaka, 564-0013

  • GSK Investigational Site

    Osaka, 570-8540

  • GSK Investigational Site

    Osaka, 573-0153

  • GSK Investigational Site

    Osaka, 576-0041

  • GSK Investigational Site

    Osaka, 591-8037

  • GSK Investigational Site

    Osaka, 591-8555

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Saitama, 349-1105

  • GSK Investigational Site

    Shizuoka, 430-8525

  • GSK Investigational Site

    Shizuoka, 434-8511

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 103-0028

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 134-0083

  • GSK Investigational Site

    Tokyo, 140-0011

  • GSK Investigational Site

    Tokyo, 140-0013

  • GSK Investigational Site

    Tokyo, 153-0051

  • GSK Investigational Site

    Tokyo, 158-8531

  • GSK Investigational Site

    Tokyo, 171-0014

  • GSK Investigational Site

    Tokyo, 187-0002

  • GSK Investigational Site

    Tokyo, 190-0014

  • GSK Investigational Site

    Tokyo, 194-0023

  • GSK Investigational Site

    Tokyo, 198-0042

  • GSK Investigational Site

    Tokyo, 204-8522

  • GSK Investigational Site

    Toyama, 930-0982

  • GSK Investigational Site

    Toyama, 931-8553

  • GSK Investigational Site

    Toyama, 937-0042

  • GSK Investigational Site

    Toyama, 938-8502

  • GSK Investigational Site

    Toyama, 939-8511

  • GSK Investigational Site

    Yamaguchi, 755-0241

Other trials in Japan

Germany20 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 80539

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49074

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

Other trials in Germany

United States17 sites

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Russia15 sites

  • GSK Investigational Site

    Chelyabinsk, 454106

  • GSK Investigational Site

    Izhevsk, 426063

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Khantymansiysk, 628012

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 125315

  • GSK Investigational Site

    Novosibirsk, 630089

  • GSK Investigational Site

    Novosibirsk, 630099

  • GSK Investigational Site

    Novosibirsk, 630102

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 195271

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saint Petesburg, 195030

Other trials in Russia

South Africa11 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7572

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Gatesville, 7764

  • GSK Investigational Site

    Meyerspark, Gauteng, 0184

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • GSK Investigational Site

    Pretoria, Gauteng, 0183

  • GSK Investigational Site

    Tygerberg, 7505

  • GSK Investigational Site

    Welkom, Free State, 9460

Other trials in South Africa

Ukraine11 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kremenchuk, 39617

  • GSK Investigational Site

    Kyiv, 02232

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Mykolayiv, 54003

  • GSK Investigational Site

    Odesa, 65025

  • GSK Investigational Site

    Vinnytsia, 21029

Other trials in Ukraine

Romania10 sites

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Brăila, 810003

  • GSK Investigational Site

    Brasov, 500118

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Comuna Alexandru Cel Bun, 617507

  • GSK Investigational Site

    Craiova, 200515

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Ploieşti, 100184

  • GSK Investigational Site

    Ploieşti, 100379

  • GSK Investigational Site

    Suceava, 720284

Other trials in Romania

South Korea10 sites

  • GSK Investigational Site

    Bucheon-si, 420-717

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Incheon, 403-720

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 100-032

  • GSK Investigational Site

    Seoul, 130-709

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 140-743

  • GSK Investigational Site

    Seoul, 150-713

  • GSK Investigational Site

    Seoul, 156-755

Other trials in South Korea

Bulgaria8 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Varna, 9000

  • GSK Investigational Site

    Vidin, 3700

Other trials in Bulgaria

Poland8 sites

  • GSK Investigational Site

    Bialystok, 15-044

  • GSK Investigational Site

    Gdynia, 81-384

  • GSK Investigational Site

    Krakow, 31-011

  • GSK Investigational Site

    Krakow, 31-024

  • GSK Investigational Site

    Lodz, 90-242

  • GSK Investigational Site

    Skierniewice, 96-100

  • GSK Investigational Site

    Warsaw, 01-192

  • GSK Investigational Site

    Wroclaw, 50-088

Other trials in Poland

Taiwan6 sites

  • GSK Investigational Site

    Keelung, 20401

  • GSK Investigational Site

    New Taipei City, 23148

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Taichung, 407

  • GSK Investigational Site

    Taichung, 427

Other trials in Taiwan

About this study

Official title: A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared With Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Being tested
Fluticasone Furoate/Vilanterol, Vilanterol
Keywords
COPD, Fluticasone Furoate (FF), Vilanterol (VI), Dry Powder Inhaler
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone Furoate/VilanterolDrug

    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

  • VilanterolDrug

    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

Study groups in NCT02105974
Study groupRoleWhat they receive
Fluticasone Furoate/Vilanterol 100/25 Inhalation PowderExperimentalInhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)
Receives: Drug: Fluticasone Furoate/Vilanterol
Vilanterol 25 Inhalation PowderExperimentalLong-acting beta2-agonist (LABA)
Receives: Drug: Vilanterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) 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. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.

    Measured: Baseline to Day 84

Secondary outcomes (2)

  1. Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period

    Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol [salbutamol] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol [salbutamol]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region.

    Measured: BL (Week -1), Week 1 to Week 12

  2. Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation

    Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented.

    Measured: From the start of double blind study medication until visit 7 (week 12)/Early withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study start7 Apr 2014
  3. Primary completion8 Jul 2015
  4. Study completion8 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,621 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105974
Sponsor's protocol ID
200820
Status last verified
Jan 2018
First submitted
3 Apr 2014
Last updated
24 Jan 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 28137501

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate/Vilanterol and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 237 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 237 sites in Japan, Germany, United States, Russia, South Africa and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 (time frame: Baseline to Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02105974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.

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Clinical Trial NCT02105974 | AzTrials