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Pulmonary Disease, Chronic ObstructivePhase 4NCT02799784

An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients

A Phase 4 study testing UMEC/VI, TIO/OLO and Albuterol/salbutamol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in 4 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 primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. 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, TIO/OLO and Albuterol/salbutamol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
35 sitesin 4 countries
Study dates
14 Jul 2016to 27 Apr 2017
Phase
Phase 4
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

  • Outpatients of either sex, 40 years of age or older at Visit 1, and with a diagnosis of chronic obstructive pulmonary disease (COPD) defined by the American Thoracic Society/European Respiratory Society (ERS)
  • A signed and dated written informed consent prior to study participation
  • A female is eligible to enter and participate in the study if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test); not lactating; and of non-reproductive potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile), which is defined as pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral or tubal occlusion ; hysterectomy; documented bilateral oophorectomy.
  • Postmenopausal is defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment OR
  • A female of reproductive potential, has a negative pregnancy test at screening, and agrees to one of the methods below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from methods used consistently and correctly (i.e., in accordance with the local approved product label and per study investigator discretion and the instructions of the physician from 30 days prior to the first dose of study medication and until to follow-up contact):
  • GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP (this list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis).
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  • Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label
  • Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label
  • Oral Contraceptive, either combined or progestogen alone
  • Injectable progestogen
  • Contraceptive vaginal ring
  • Percutaneous contraceptive patches
  • Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
  • These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-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.
  • A pre and post-albuterol/salbutamol forced expiratory volume in one second (FEV1)/Forced Vital Capacity ratio of <0.70 and a post-albuterol/salbutamol FEV1 of <=70% to >=50 % of predicted normal values at Visit 1. Predicted values will be based upon the ERS' Global Lung Function Initiative
  • A score of >=2 on the Modified Medical Research Council Dyspnea Scale 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
  • Subjects with alpha-1 antitrypsin deficiency as the underlying cause of COPD
  • Subjects with active tuberculosis are excluded. Subjects with other respiratory disorders (e.g. clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases) are excluded if these conditions are the primary cause of their respiratory symptoms.
  • Any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any subject who has any other condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment
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  • Investigational Product should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as:
  • Myocardial infarction or unstable angina in the last 6 months Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months New York Heart Association Class IV heart failure
  • Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate
  • Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should be excluded unless, in the opinion of the study physician, the benefit outweighs the risk
  • Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening (V1) and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable).
  • Other respiratory tract infections that have not resolved at least 7 days prior to Screening (V1).
  • Subjects with lung volume reduction surgery (including procedures such as endobronchial valves) within the 12 months prior to Screening (V1).
  • The Investigator will determine the clinical significance of each abnormal electrocardiogram finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial
  • Unable to withhold albuterol/salbutamol for the 4-hour (h) period required prior to spirometry testing at each study visit
  • Use of the pre-defined medications according to the pre-defined defined time intervals prior to Screening (Visit 1)
  • Use of long-term oxygen therapy described as resting oxygen therapy >3 liter (L)/minute (min) at screening. (Oxygen use <=3 L/min flow is not exclusionary, and patients may adjust oxygen levels as needed during the study.)
  • Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol).
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening (Visit 1). Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
  • A known or suspected history of alcohol or drug abuse within 2 years prior to Screening (Visit 1) that in the opinion of the investigator would prevent the subject from completing the study procedures
  • Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study
  • 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

35 sites in 4 countries.

35 sites in 4 countries

United Kingdom11 sites

  • GSK Investigational Site

    Addlestone, Surrey, KT15 2BH

  • GSK Investigational Site

    Bristol, BS37 4AX

  • GSK Investigational Site

    Cheadle, Cheshire, SK8 5LL

  • GSK Investigational Site

    Chesterfield, Derbyshire, S40 4AA

  • GSK Investigational Site

    Chippenham, SN15 2SB

  • GSK Investigational Site

    Manchester, Greater Manchester, M22 4DH

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Romford, Essex, RM1 3PJ

  • GSK Investigational Site

    Salford, Greater Manchester, M6 7HL

  • GSK Investigational Site

    Sidcup, Kent, DA14 6LT

  • GSK Investigational Site

    Swinton, M27 8HP

Other trials in United Kingdom

United States9 sites

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

Other trials in United States

Germany8 sites

  • 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

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Jerichow, Saxony-Anhalt, 39319

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Spain7 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Girona, 17005

  • GSK Investigational Site

    Loja/ Granada, 18300

  • GSK Investigational Site

    Marbella - Málaga, Andalusia, 29603

  • GSK Investigational Site

    Mérida (Badajoz), 06800

  • GSK Investigational Site

    Ponferrada (León), 24411

  • GSK Investigational Site

    Valladolid, 47012

Other trials in Spain

About this study

Official title: A Randomized, Open-Label, 8-Week Cross-Over Study to Compare Umeclidinium/Vilanterol With Tiotropium/Olodaterol Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD.

This is a multicentre, randomized, open label, 2 period crossover complete block design study.

Read more

Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram [mcg] once-daily [QD]) administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be followed by a 3-week washout period and one-week follow-up period. The total duration of subject participation in the study will be approximately 22 weeks.

ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a registered trademark of Boehringer Ingelheim.

Being tested
UMEC/VI, TIO/OLO, Albuterol/salbutamol
Keywords
tiotropium, COPD, olodaterol, Umeclidinium bromide, efficacy, vilanterol
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/VIDrug

    ELLIPTA dry powder inhaler (DPI) will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5 mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously

  • TIO/OLODrug

    TIO/OLO inhalation spray will be supplied as an inhalation spray delivered using a RESPIMAT inhaler. Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent to 2.5 mcg olodaterol)

  • Albuterol/salbutamolDrug

    Albuterol/salbutamol will be supplied as an inhalation spray via metered dose inhaler and will be issued for reversibility testing at Visit 1. Albuterol/salbutamol will be permitted throughout the study for use as-needed

Study groups in NCT02799784
Study groupRoleWhat they receive
Sequence 1: UMEC/VI 62.5/ 25 mcgExperimentalSubjects will receive UMEC/VI 62.5/25 mcg (as one inhalation) administered QD via the ELLIPTA Inhaler for 8 weeks followed by a washout period of 3 weeks
Receives: Drug: UMEC/VI; Drug: Albuterol/salbutamol
Sequence 2: TIO/OLO 5/5 mcgExperimentalSubjects will receive TIO/OLO 5/5 mcg (as 2 inhalations of 2.5/2.5 mcg per inhalation) administered QD via the RESPIMAT inhaler for 8 weeks followed by a washout period of 3 weeks
Receives: Drug: TIO/OLO; Drug: Albuterol/salbutamol

What is being measured

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

  1. Trough Forced Expiratory Volume in One Second (FEV1) at Week 8

    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 was defined as 23 and 24 hour post-dose FEV1 measurements. All par. in the Intent To Treat (ITT) Population who were not identified as full protocol deviators were included in Per-Protocol (PP) Population. ITT Population, comprised of all randomized subjects, who received at least one dose of study medication.

    Measured: Week 8

Timeline

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

  1. First posted15 Jun 2016 (estimated)
  2. Study start14 Jul 2016
  3. Primary completion27 Apr 2017
  4. Study completion27 Apr 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799784
Sponsor's protocol ID
204990
Status last verified
Jun 2018
First submitted
2 Jun 2016
Last updated
2 Jul 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Alcazar Navarrete B, Boucot I, Naya I, Tombs L, Lipson DA, Compton C, Sousa AR, Feldman G. Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naive Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis. Pulm Ther. 2018 Dec;4(2):171-183. doi: 10.1007/s41030-018-0057-7. Epub 2018 Jun 20.

    PubMed 32026389

  • Feldman GJ, Sousa AR, Lipson DA, Tombs L, Barnes N, Riley JH, Patel S, Naya I, Compton C, Alcazar Navarrete B. Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study. Adv Ther. 2017 Nov;34(11):2518-2533. doi: 10.1007/s12325-017-0626-4. Epub 2017 Nov 1.

    PubMed 29094315

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing UMEC/VI, TIO/OLO and Albuterol/salbutamol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in 4 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 17 inclusion and 22 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United Kingdom, United States, Germany, Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Jul 2018). 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?

Trough Forced Expiratory Volume in One Second (FEV1) at Week 8 (time frame: Week 8). 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 NCT02799784, which also lists 2 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 2 Jul 2018.

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