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Pulmonary Disease, Chronic ObstructivePhase 3NCT01879410

A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI and FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 sites in 7 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

Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of 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?
UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI and FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
72 sitesin 7 countries
Study dates
13 Jun 2013to 9 Jan 2014
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: A signed and dated written informed consent prior to study participation.
  • Age: Subjects 40 years of age or older at Visit 1.
  • 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). Or if of child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods mentioned in the protocol used consistently and correctly:
  • Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society as follows: COPD is a preventable and treatable disease state 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.
  • Smoking history: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history.
  • Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0.70 and a post-salbutamol FEV1 of >=30% and <=70% of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations at Visit 1.
  • Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.

Who cannot join

  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: A current diagnosis of asthma.
  • Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject, who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary.
  • Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). 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.
  • Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.
  • Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1.
Show all 17Show fewer
  • History of COPD Exacerbation: A documented history 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.
  • Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
  • 12-Lead electrocardiogram (ECG): An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility.
  • Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids - 12 weeks, Systemic, oral or parenteral corticosteroids - 6 weeks, Antibiotics (for lower respiratory tract infection) - 6 weeks, Cytochrome P450 3A4 strong inhibitors - 6 weeks, Herbal medications potentially containing oral or systemic steroids - 6 weeks, Inhaled corticosteroids (ICS) - 30 days, Long-acting beta2-agonist (LABA)/ICS combination products - 30 days, Phosphodiesterase 4 (PDE4) inhibitors (e.g., roflumilast) - 14 days, Inhaled long-acting anticholinergics - 7 days, Olodaterol and Indacaterol - 10days, Theophyllines - 48 hours, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton) - 48 hours, Oral beta2-agonists Long-acting-48 hours/Short-acting - 12 hours, Inhaled long acting beta2-agonists (LABA, e.g., salmeterol, formoterol, indacaterol) - 48 hours, Inhaled sodium cromoglycate or nedocromil sodium - 24 hours, Inhaled short acting beta2-agonists - 4 hours, Inhaled short-acting anticholinergics - 4 hours, Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products - 4 hours, Any other investigational medication - 30 days or within 5 drug half-lives (whichever is longer).
  • Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <=12 hours per day) is not ex-clusionary.
  • Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
  • Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • Inability to read: A subject will not be eligible for the study if in the opinion of the investigator the subject cannot read.

Trial locations and contacts

72 sites in 7 countries.

72 sites in 7 countries

Russia22 sites

  • GSK Investigational Site

    Arkhangelsk, 153000

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Chelyabinsk, 454091

  • GSK Investigational Site

    Chita, 672000

  • GSK Investigational Site

    Ivanovo, 153005

  • GSK Investigational Site

    Izhevsk, 426063

  • GSK Investigational Site

    Moscow, 105229

  • GSK Investigational Site

    Omsk, 644112

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Smolensk, 214 019

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Vladimir, 600023

  • GSK Investigational Site

    Vladivostok, 690950

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yaroslavl, 150002

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150010

  • GSK Investigational Site

    Yekaterinburg, 620039

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

United States15 sites

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Renton, Washington, 98055

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

Chile8 sites

  • GSK Investigational Site

    Concepción, Región Del Biobio, 4070038

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8880465

  • GSK Investigational Site

    Talca, Región Metro de Santiago, 3460001

  • GSK Investigational Site

    Talcahuano, 4270918

  • GSK Investigational Site

    Temuco, Región de La Araucania

Other trials in Chile

Romania8 sites

  • GSK Investigational Site

    Brăila, 810003

  • GSK Investigational Site

    Bucharest, 010457

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Comuna Alexandru Cel Bun, 617507

  • GSK Investigational Site

    Constanța, 900002

  • GSK Investigational Site

    Craiova, 200515

  • GSK Investigational Site

    Focşani, 620043

Other trials in Romania

South Africa8 sites

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Die Wilgers, 0041

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Gatesville, 7764

  • GSK Investigational Site

    Meyerspark, Gauteng, 0184

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Reiger Park, 1459

  • GSK Investigational Site

    Somerset West, 7130

Other trials in South Africa

Norway6 sites

  • GSK Investigational Site

    Bergen, N-5021

  • GSK Investigational Site

    Bodø, 8005

  • GSK Investigational Site

    Hamar, 2317

  • GSK Investigational Site

    Kløfta, 2040

  • GSK Investigational Site

    Stavanger, 4005

  • GSK Investigational Site

    Trondheim, 7030

Other trials in Norway

Mexico5 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    México DF, 14050

  • GSK Investigational Site

    Monterrey, Nuevo León, 64000

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

  • GSK Investigational Site

    Oaxaca City, 68000

Other trials in Mexico

About this study

Official title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD

Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram [mcg] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.

Being tested
UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI, FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS, Placebo DISKUS, Placebo NDPI
Keywords
GSK573719, lung function, salmeterol (SAL), umeclidinium bromide (UMEC), GW642444, Chronic obstructive pulmonary disease, Novel Dry Powder Inhaler (NDPI), fluticasone propionate (FP), vilanterol (VI)
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.

  • UMEC/VI Inhalation Powder 62.5/25 mcg via NDPIDrug

    The drug is administered via NDPI as one inhalation once daily in the morning. NDPI has two strips, each containing 30 blisters of medication. The first strip has UMEC blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 62.5 mcg per blister and the second strip has VI blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 25 mcg per blister.

  • FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUSDrug

    The drug is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains a single strip with 60 blisters of medication. The strip has 250 mcg of fluticasone propionate and 50 mcg of salmeterol per blister in the form of dry white powder.

  • Placebo DISKUSDrug

    Placebo is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains 1 strip with 60 blisters of placebo in the form of dry white powder.

  • Placebo NDPIDrug

    Placebo is administered via NDPI as one inhalation once daily in the morning. The inhaler contains 2 strips with 30 blisters of placebo per strip in the form of dry white powder.

Study groups in NCT01879410
Study groupRoleWhat they receive
UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS armExperimentalSubjects will receive one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning via the NDPI and one inhalation of placebo in the morning and evening via ACCUHALER/DISKUS inhaler
Receives: Drug: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI; Drug: Placebo DISKUS
FSC via ACCUHALER/DISKUS + placebo NDPI armActive comparatorSubjects will receive one inhalation of FSC 250/50 mcg in the morning and evening via ACCUHALER/DISKUS inhaler and one inhalation of placebo administered once-daily in the morning via NDPI
Receives: Drug: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS; Drug: Placebo NDPI

What is being measured

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

  1. Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.

    Measured: Baseline and Day 84

Secondary outcomes (1)

  1. Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.

    Measured: Baseline and Day 85

Timeline

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

  1. First posted17 Jun 2013 (estimated)
  2. Study start13 Jun 2013
  3. Primary completion1 Jan 2014
  4. Study completion9 Jan 2014

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
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01879410
Sponsor's protocol ID
114951
Status last verified
Oct 2017
First submitted
13 Jun 2013
Last updated
8 Nov 2017
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

  • Donohue JF, Worsley S, Zhu CQ, Hardaker L, Church A. Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med. 2015 Jul;109(7):870-81. doi: 10.1016/j.rmed.2015.04.018. Epub 2015 May 8.

    PubMed 26006754

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI and FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 sites in 7 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 8 inclusion and 17 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Russia, United States, Chile, Romania, South Africa and 2 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 15 Aug 2014). 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?

Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (time frame: Baseline and 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 NCT01879410, 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 8 Nov 2017.

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