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Pulmonary Disease, Chronic ObstructivePhase 3NCT01817764

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

A Phase 3 study testing Umeclidinium/vilanterol and Fluticasone propionate/salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 59 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

This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with 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?
Umeclidinium/vilanterol and Fluticasone propionate/salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
707 participants
Where
59 sitesin 7 countries
Study dates
1 Mar 2013to 25 Oct 2013
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
  • A signed and dated written informed consent prior to study participation
  • Male or female subjects, 40 years of age or older at Visit 1
  • 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). - A female is eligible to enter and participate in the study if she is of: Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods as listed in the protocol used consistently and correctly.
  • An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society as follows: Chronic obstructive pulmonary disease 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/Forced Vital Capacity (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

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study
  • A current diagnosis of asthma
  • Other Respiratory Disorders: Known α-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 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, 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 exclusionary
  • 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

59 sites in 7 countries.

59 sites in 7 countries

Ukraine13 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Donetsk, 83003

  • GSK Investigational Site

    Donetsk, 83114

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 01114

  • GSK Investigational Site

    Kyiv, 02091

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Kyiv, 04201

  • GSK Investigational Site

    Poltava, 36024

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Yalta, 98603

Other trials in Ukraine

Romania10 sites

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Ploieşti, 100184

  • GSK Investigational Site

    Ploieşti, 100379

  • GSK Investigational Site

    Râmnicu Vâlcea, 240564

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

United States9 sites

  • GSK Investigational Site

    Clearwater, Florida, 33765-2616

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

Other trials in United States

Argentina9 sites

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1425FVH

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Chile9 sites

  • GSK Investigational Site

    Quillota, Valparaiso, 2260000

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500800

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8910131

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Santiago, 8910131

  • GSK Investigational Site

    Santiago

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

  • GSK Investigational Site

    Viña del Mar, 2570017

Other trials in Chile

Greece8 sites

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 151 26

  • GSK Investigational Site

    Haidari / Athens, 124 62

  • GSK Investigational Site

    Heraklion, Crete, 71110

  • GSK Investigational Site

    Rethymnon, Crete, 74100

  • GSK Investigational Site

    Thessaloniki, 56429

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Peru1 site

  • GSK Investigational Site

    Lima, Lima Province, Lima 27

Other trials in Peru

About this study

Official title: DB2114930: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD

This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.

Being tested
Umeclidinium/vilanterol, Fluticasone propionate/salmeterol, Placebo
Keywords
umeclidinium bromide (UMEC), vilanterol (VI), salmeterol (SAL), fluticasone propionate (FP), Novel Dry Powder Inhaler (NDPI), Chronic obstructive pulmonary disease, GW642444, GSK573719, lung function
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.

  • Umeclidinium/vilanterolDrug

    Dry white powder delivered via NDPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning

  • Fluticasone propionate/salmeterolDrug

    Dry white powder delivered via ACCUHALER/DISKUS (1 strip with 60 blisters, containing 250 mcg fluticasone propionate and 50 mcg salmeterol per blister), administered as one inhalation of FSC 250/50 mcg each morning and evening

  • PlaceboDrug

    Placebo will be administered via ACCUHALER/DISKUS or NDPI. Dry white powder administered as one inhalation each morning and evening via ACCUHALER/DISKUS (1 strip with 60 blisters containing placebo) OR once-daily in the morning via NDPI (2 strips with 30 blisters each, containing placebo)

Study groups in NCT01817764
Study groupRoleWhat they receive
Umeclidinium/vilanterol ArmExperimentalThe subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via the NDPI and placebo administered as one inhalation each morning and evening via ACCUHALER/DISKUS
Receives: Drug: Umeclidinium/vilanterol; Drug: Placebo
Fluticasone propionate/salmeterol ArmActive comparatorThe subjects will receive FSC 250/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS and placebo administered once-daily in the morning via NDPI
Receives: Drug: Fluticasone propionate/salmeterol; Drug: Placebo

What is being measured

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

  1. Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment 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. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.

    Measured: Baseline and Day 84

Secondary outcomes (1)

  1. Change From Baseline in Trough FEV1 on Day 85

    Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.

    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 posted25 Mar 2013 (estimated)
  2. Study start1 Mar 2013
  3. Primary completion1 Oct 2013
  4. Study completion25 Oct 2013

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
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817764
Sponsor's protocol ID
114930
Status last verified
Oct 2017
First submitted
21 Mar 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 Umeclidinium/vilanterol and Fluticasone propionate/salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 59 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 59 sites in Ukraine, Romania, United States, Argentina, Chile 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 29 May 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 in 24-hour Weighted-mean Serial FEV1 on Treatment 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 NCT01817764, 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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