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Pulmonary Disease, Chronic ObstructivePhase 3NCT01822899

A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Umeclidinium bromide/Vilanterol and Fluticasone propionate/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 78 sites in 8 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 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?
Umeclidinium bromide/Vilanterol and Fluticasone propionate/Salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
717 participants
Where
78 sitesin 8 countries
Study dates
4 Apr 2013to 7 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
  • 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 Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol used consistently and correctly
  • Diagnosis: 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 smoking 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 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 ECG: An abnormal and significant electrocardiogram (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

78 sites in 8 countries.

78 sites in 8 countries

Russia19 sites

  • GSK Investigational Site

    Barnaul, 656038

  • GSK Investigational Site

    Blagoveshchensk, 675000

  • GSK Investigational Site

    Kaluga, 248007

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Khantymansiysk, 628012

  • GSK Investigational Site

    Moscow, 105 077

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Moscow, 121 309

  • GSK Investigational Site

    Moscow, 123182

  • GSK Investigational Site

    Moscow, 123367

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Orenburg, 460018

  • GSK Investigational Site

    Petrozavodsk, 185019

  • GSK Investigational Site

    Ryazan, 390039

  • GSK Investigational Site

    Saint Pertersburg, 196247

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Ufa, 450000

Other trials in Russia

Germany15 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10629

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 10789

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dillingen an der Donau, Bavaria, 89407

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

Hungary13 sites

  • GSK Investigational Site

    Balassagyarmat, 2660

  • GSK Investigational Site

    Budaörs, 2040

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Debrecen, 4043

  • GSK Investigational Site

    Farkasgyepű, 8552

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Miskolc, 3529

  • GSK Investigational Site

    Mosonmagyaróvár, 9200

  • GSK Investigational Site

    Nyíregyháza, 4400

  • GSK Investigational Site

    Pécs, H-7621

  • GSK Investigational Site

    Szeged, 6722

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szikszó, 3800

Other trials in Hungary

Czechia8 sites

  • GSK Investigational Site

    Benešov, 256 30

  • GSK Investigational Site

    Cvikov, 471 54

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Kroměříž, 767 55

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Rokycany, 337 01

  • GSK Investigational Site

    Teplice, 415 10

  • GSK Investigational Site

    Třebíč, 674 01

Other trials in Czechia

Spain7 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Barcelona, Catalonia, 08017

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Pama de Mallorca, 07010

  • GSK Investigational Site

    Ponferrada (León), 24411

  • GSK Investigational Site

    Valladolid, 47012

Other trials in Spain

Netherlands6 sites

  • GSK Investigational Site

    Dordrecht, 3318 AT

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Kloosterhaar, 7694 AC

  • GSK Investigational Site

    Sneek, 8601 ZR

Other trials in Netherlands

Poland6 sites

  • GSK Investigational Site

    Gdansk, 80-169

  • GSK Investigational Site

    Inowrocław, 88-100

  • GSK Investigational Site

    Krakow, 31-024

  • GSK Investigational Site

    Poznan, 60-773

  • GSK Investigational Site

    Skierniewice, 96-100

  • GSK Investigational Site

    Słupsk, 76-200

Other trials in Poland

Denmark4 sites

  • GSK Investigational Site

    Copenhagen, 2400

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Roskilde, 4000

Other trials in Denmark

About this study

Official title: DB2116134: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/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 Chronic Obstructive Pulmonary Disease (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 500/50 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 bromide/Vilanterol, Placebo ACCUHALER/DISKUS, Fluticasone propionate/Salmeterol, Placebo NDPI
Keywords
Novel Dry Powder Inhaler (NDPI), umeclidinium bromide (UMEC), GSK573719, lung function, GW642444, salmeterol (SAL), fluticasone propionate (FP), vilanterol (VI), Chronic obstructive pulmonary disease
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 bromide/VilanterolDrug

    Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip).

  • Placebo ACCUHALER/DISKUSDrug

    Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).

  • Fluticasone propionate/SalmeterolDrug

    Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).

  • Placebo NDPIDrug

    Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip).

Study groups in NCT01822899
Study groupRoleWhat they receive
Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUSExperimentalSubjects will receive UMEC/ VI 62.5/25 mcg, one inhalation administered once-daily in the morning via the NDPI and one placebo ACCUHALER/DISKUS administered as one inhalation each morning and evening.
Receives: Drug: Umeclidinium bromide/Vilanterol; Drug: Placebo ACCUHALER/DISKUS
Fluticasone propionate/Salmeterol + placebo NDPIActive comparatorSubjects will receive FSC 500/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once daily in the morning via NDPI.
Receives: Drug: Fluticasone propionate/Salmeterol; 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 Serial Forced Expiratory Volume in One 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 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.

    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. BL 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 FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is 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, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL 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.

    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 posted2 Apr 2013 (estimated)
  2. Study start4 Apr 2013
  3. Primary completion1 Oct 2013
  4. Study completion7 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
717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01822899
Sponsor's protocol ID
116134
Status last verified
Aug 2017
First submitted
28 Mar 2013
Last updated
6 Sep 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

  • Singh D, Worsley S, Zhu CQ, Hardaker L, Church A. Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. BMC Pulm Med. 2015 Aug 19;15:91. doi: 10.1186/s12890-015-0092-1.

    PubMed 26286141

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umeclidinium bromide/Vilanterol and Fluticasone propionate/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 78 sites in 8 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Russia, Germany, Hungary, Czechia, Spain and 3 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 (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One 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 NCT01822899, 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 6 Sep 2017.

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