AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT01017952

A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 183 sites in 15 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

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD) 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?
FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,635 participants
Where
183 sitesin 15 countries
Study dates
25 Sep 2009to 17 Oct 2011
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 or female subjects A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. OR
  • Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
  • Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or
  • Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
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  • Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
  • Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or
  • Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
  • Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
  • An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
  • Estrogenic vaginal ring; or
  • Percutaneous contraceptive patches
  • Age: ≥40 years of age at Screening (Visit 1)
  • COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: 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 also produces significant systemic consequences.
  • 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. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. Number of pack years = (number of cigarettes per day/20) x number of years smoked
  • Severity of Disease:
  • Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1)
  • Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The study provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.
  • History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.

Who cannot join

  • 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. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
  • 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)
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  • 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. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study.
  • Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myasthenia Gravis, etc).
  • A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
  • Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least ≥ 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
  • 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. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • 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 medications (e.g., beta-agonists, corticosteroid) 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 study physician, 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 and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
  • Additional medication: Unable to stop using 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. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
  • 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 previously been randomized to treatment with GW642444 Inhalation Powder in the B2C111045 study, randomized to treatment in the HZC111348 study or have participated in the HZC112207, HZC102871, HZC102970, or HZC110946 studies. 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.
  • 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

183 sites in 15 countries.

183 sites in 15 countries

United States89 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Asheville, North Carolina, 28803

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Brockton, Massachusetts, 02301

  • GSK Investigational Site

    Burlington, North Carolina, 27215

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Centerville, Ohio, 45459

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08003

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Cocoa, Florida, 32927

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbia, Missouri, 65212

  • GSK Investigational Site

    Columbia, South Carolina, 29201

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Council Bluffs, Iowa, 51503

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Edina, Minnesota, 55438

  • GSK Investigational Site

    Elk Grove Village, Illinois, 60007

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fall River, Massachusetts, 02720

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fresno, California, 93710

  • GSK Investigational Site

    Fresno, California, 93726

  • GSK Investigational Site

    Fridley, Minnesota, 55432

  • GSK Investigational Site

    Gainesville, Georgia

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hartford, Connecticut, 06105

  • GSK Investigational Site

    Hazard, Kentucky, 41701

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Kissimmee, Florida, 34741

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Lincoln, Nebraska, 68506

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Madison, Wisconsin, 53715

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Martinez, Georgia, 30907

  • GSK Investigational Site

    Miami, Florida, 33183

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Monterey Park, California, 91754

  • GSK Investigational Site

    Murrells Inlet, South Carolina, 29576

  • GSK Investigational Site

    Nashville, Tennessee, 37232

  • GSK Investigational Site

    National City, California, 91950

  • GSK Investigational Site

    New Braunfels, Texas, 78130

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    North Syracuse, New York, 13212

  • GSK Investigational Site

    Olathe, Kansas, 66061

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Ozark, Alabama, 36360

  • GSK Investigational Site

    Papillion, Nebraska, 68046

  • GSK Investigational Site

    Pelzer, South Carolina, 29669

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Phoenix, Arizona, 85012

  • GSK Investigational Site

    Phoenix, Arizona, 85023

  • GSK Investigational Site

    Pittsfield, Massachusetts, 01201

  • GSK Investigational Site

    Portland, Oregon, 97220

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Riverdale, Georgia, 30274

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Springfield, Missouri, 65803

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    St Louis, Missouri, 63143

  • GSK Investigational Site

    St. Petersburg, Florida, 33707

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Summit, New Jersey, 07091

  • GSK Investigational Site

    Tallassee, Alabama, 36078

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    Thornton, Colorado, 80233

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Torrance, California, 90502

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Van Nuys, California, 91405

  • GSK Investigational Site

    Wichita Falls, Texas, 76309

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Canada11 sites

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Grimsby, Ontario, L3M 1P3

  • GSK Investigational Site

    Hamilton, Ontario, L8M 1K7

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Montreal, Quebec, H2X 2P4

  • GSK Investigational Site

    Newmarket, Ontario, L3Y 5G8

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Netherlands10 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Almere Stad, 1315 RA

  • GSK Investigational Site

    Beek, 6191 JW

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Groningen, 9728 NP

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Horn, 6085 NM

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

South Africa10 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7572

  • GSK Investigational Site

    Gatesville, 7764

  • GSK Investigational Site

    Meyerspark, Gauteng, 0184

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Parktown, Gauteng, 2193

  • GSK Investigational Site

    Roodepoort, 1724

  • GSK Investigational Site

    Waterkloof Ridge, Gauteng, 0181

  • GSK Investigational Site

    Worcester, 6850

Other trials in South Africa

Italy9 sites

  • GSK Investigational Site

    Foggia, Apulia, 71100

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41124

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Rome, Lazio, 00168

  • GSK Investigational Site

    Salerno, Campania, 84100

  • GSK Investigational Site

    San Felice A Cancello Caserta, Campania, 81027

Other trials in Italy

Spain9 sites

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Cartagena (Murcia), 30202

  • GSK Investigational Site

    Elda, 03600

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Orihuela/Alicante, 03314

  • GSK Investigational Site

    Pama de Mallorca, 07010

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

Other trials in Spain

Australia8 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Kingswood, New South Wales, 2747

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Southport, Queensland, 4215

  • GSK Investigational Site

    Westmead, New South Wales, 2145

Other trials in Australia

Germany7 sites

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Wiesbaden, Hesse, 65183

Other trials in Germany

United Kingdom6 sites

  • GSK Investigational Site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • GSK Investigational Site

    Cambridge, CB2 0QQ

  • GSK Investigational Site

    Chertsey, Surrey, KT16 0PZ

  • GSK Investigational Site

    Southampton, Hampshire, SO16 6YD

  • GSK Investigational Site

    Trowbridge, Wiltshire, BA14 8QA

  • GSK Investigational Site

    Wythenshawe, Manchester, M23 9LT

Other trials in United Kingdom

Argentina5 sites

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000DGF

Other trials in Argentina

Denmark5 sites

  • GSK Investigational Site

    Aalborg, 9100

  • GSK Investigational Site

    Aarhus C, 8000

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Peru4 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Lima, Lima Province

  • GSK Investigational Site

    San Miguel, Lima region, Lima 32

  • GSK Investigational Site

    Santiago de Surco, Lima region, Lima 33

Other trials in Peru

Sweden4 sites

  • GSK Investigational Site

    Åtvidaberg, SE-597 26

  • GSK Investigational Site

    Bankeryd, SE-564 31

  • GSK Investigational Site

    Karlskrona, SE-371 41

  • GSK Investigational Site

    Lidingö, SE-181 58

Other trials in Sweden

Chile3 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500691

  • GSK Investigational Site

    Talcahuano, 4270918

Other trials in Chile

Mexico3 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44600

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

About this study

Official title: HZC102970: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Being tested
FF/GW642444 Inhalation Powder, GW642444 Inhalation Powder
Keywords
Safety, COPD, FEV1, Efficacy
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.

  • FF/GW642444 Inhalation PowderDrug

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

  • GW642444 Inhalation PowderDrug

    Long Acting Beta Agonist(LABA) Inhalation Powder

Study groups in NCT01017952
Study groupRoleWhat they receive
FF/GW642444 Inhalation Powder 100/25 mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
FF/GW642444 Inhalation Powder 50mcg/25mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
FF/GW642444 Inhalation Powder 200/25 mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
GW642444 25mcg QDExperimentalLong Acting Beta Agonist(LABA)
Receives: Drug: GW642444 Inhalation Powder

What is being measured

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

  1. Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean

    The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.

    Measured: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal

Secondary outcomes (3)

  1. Time to First Occurrence of Moderate or Severe COPD Exacerbation

    Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.

    Measured: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal

  2. Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean

    The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.

    Measured: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal

  3. Change From Baseline in Trough FEV1 at Week 52 (Visit 11)

    Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.

    Measured: Baseline to Visit 11 (Week 52)/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 posted23 Nov 2009 (estimated)
  2. Study start25 Sep 2009
  3. Primary completion1 Oct 2011
  4. Study completion17 Oct 2011

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
1,635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01017952
Sponsor's protocol ID
102970
Status last verified
Aug 2018
First submitted
19 Nov 2009
Last updated
31 Aug 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

  • Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.

    PubMed 24429127

  • Largajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.

    PubMed 31197640

  • Hinds DR, DiSantostefano RL, Le HV, Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open. 2016 Jun 1;6(6):e010099. doi: 10.1136/bmjopen-2015-010099.

    PubMed 27251682

  • Crim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.

    PubMed 25490706

  • 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.

    PubMed 24314123

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 183 sites in 15 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 20 inclusion and 25 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, Canada, Netherlands, South Africa, Italy and 10 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 19 Aug 2013). 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?

Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (time frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal). 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 NCT01017952, which also lists 5 linked publications.

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 31 Aug 2018.

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