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Pulmonary Disease, Chronic ObstructivePhase 3NCT01772147

Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.

A Phase 3 study testing Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 55 sites in 5 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 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate… 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 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
55 sitesin 5 countries
Study dates
Jan 2013to Aug 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 if of non-child-bearing potential, or if of child bearing potential, has a megative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed 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.
  • 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)]. Former 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-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations.
  • Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale 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 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 conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease.
  • 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: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) 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 anticholingeric.
  • Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
Show all 16Show fewer
  • Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
  • 12-Lead 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. Specific ECG findings that preclude subject eligibility are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4.
  • Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Medications Prior to Screening: use of certain medications for the protocol-specific times prior to Visit 1.
  • 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., albuterol/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, subinvestigator, study coordinator, or employee of the participating investigator.
  • Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.

Trial locations and contacts

55 sites in 5 countries.

55 sites in 5 countries

United States17 sites

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tampa, Florida, 33603

Other trials in United States

Czechia12 sites

  • GSK Investigational Site

    Karlovy Vary, 360 09

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Lovosice, 410 02

  • GSK Investigational Site

    Olomouc, 772 00

  • GSK Investigational Site

    Ostrava - Poruba, 70868

  • GSK Investigational Site

    Pilsen, 301 00

  • GSK Investigational Site

    Pilsen, 323 00

  • GSK Investigational Site

    Prague, 140 46

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Prague, 170 00

  • GSK Investigational Site

    Tábor, 390 19

  • GSK Investigational Site

    Teplice, 415 10

Other trials in Czechia

Chile9 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, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500800

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8880465

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Talca, Región Metro de Santiago, 3460001

  • GSK Investigational Site

    Viña del Mar, Valparaiso, 2520024

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

Poland9 sites

  • GSK Investigational Site

    Elblag, 82-300

  • GSK Investigational Site

    Gdynia, 81-384

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Inowrocław, 88-100

  • GSK Investigational Site

    Krakow, 31-024

  • GSK Investigational Site

    Ostrów Wielkopolski, 63-400

  • GSK Investigational Site

    Piła, 64-920

  • GSK Investigational Site

    Warsaw, 01-192

  • GSK Investigational Site

    Wroclaw, 50-088

Other trials in Poland

South Korea8 sites

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Seongnam-si, Gyeonggi-do, 463-707

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 130-848

  • GSK Investigational Site

    Seoul, 134-701

  • GSK Investigational Site

    Seoul, 143-729

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Seoul, 158-710

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallelgroup Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide Inhalation Powder (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide Inhalation Powder (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks in Subjects With COPD.

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Read the detailed description

This is a multicenter, randomized, double-blind, parallel-group study. Subjects who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 4 week run-in period will enter a 12 week treatment period. There will be a 7 day follow-up period after the treatment period.

Being tested
Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg, Fluticasone propionate 250mcg/Salmeterol 50mcg
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 62.5mcgDrug

    Inhalation powder

  • Umeclidinium bromide 125mcgDrug

    Inhalation powder

  • Fluticasone propionate 250mcg/Salmeterol 50mcgDrug

    Inhalation powder

Study groups in NCT01772147
Study groupRoleWhat they receive
Umeclidinium bromideExperimentalLong-acting muscarinic antagonist (LAMA)
Receives: Drug: Umeclidinium bromide 62.5mcg; Drug: Umeclidinium bromide 125mcg
Fluticasone propionate/SalmeterolActive comparatorInhaled corticosteroid (ICS)/Long-acting beta agonist (LABA)
Receives: Drug: Fluticasone propionate 250mcg/Salmeterol 50mcg

What is being measured

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

  1. Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on 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. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was 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 at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.

    Measured: Baseline and Day 85

Secondary outcomes (3)

  1. Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose 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 FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 6-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.

    Measured: Baseline and Day 84

  2. Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12

    A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.

    Measured: Baseline and Weeks 1- 12

  3. Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12

    The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.

    Measured: Baseline and Weeks1- 12

Timeline

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

  1. First posted21 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2013
  4. Study completionAug 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
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772147
Sponsor's protocol ID
116136
Status last verified
Mar 2017
First submitted
17 Jan 2013
Last updated
23 Mar 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 55 sites in 5 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 16 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Czechia, Chile, Poland, South Korea. 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 21 Apr 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 the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (time frame: Baseline and Day 85). 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 NCT01772147.

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 23 Mar 2017.

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