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AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4NCT03474081

A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing FF/UMEC/VI, Tiotropium and Albuterol/salbutamol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 sites in 3 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

COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. 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?
FF/UMEC/VI, Tiotropium and Albuterol/salbutamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
72 sitesin 3 countries
Study dates
29 Mar 2018to 17 Jul 2019
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

  • Subjects capable of giving signed informed consent.
  • Outpatients will be included in the study.
  • Subjects 40 years of age or older at Screening (Visit 1).
  • Male or female subjects will be included; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment.
  • An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) (number of pack years = [number of cigarettes per day / 20] x number of years smoked [example given {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.
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  • A score of >=10 on the COPD Assessment Test (CAT) at Screening (Visit 1).
  • Subjects must demonstrate at Screening: A post-bronchodilator FEV1 <50 percent predicted normal or a post-bronchodilator FEV1 <80 percent predicted normal and a documented history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months. Subjects must also have a measured post albuterol/salbutamol FEV1/forced vital capacity (FVC) ratio of <0.70 at screening.
  • Subjects must have been receiving daily maintenance treatment with tiotropium alone (via the HANDIHALER or RESPIMAT®) for their COPD for at least 3 months prior to Screening.

Who cannot join

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
  • Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD.
  • Subjects with active tuberculosis, lung cancer, and clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary diseases.
  • Subjects who have undergone lung volume reduction surgery within the 12 months prior to Screening.
  • Immune suppression (e.g. advanced human immunodeficiency virus [HIV] with high viral load and low cluster of differentiation 4 [CD4] count, lupus on immunosuppressant's) that in the opinion of the investigator would increase risk of pneumonia or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Subjects at potentially high risk for pneumonia (e.g. very low body mass index [BMI], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
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  • Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable).
  • Respiratory tract infection that has not resolved at least 7 days prior to Screening.
  • Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerized tomography [CT] scan obtained within 3 months prior to screening). For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS).
  • Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. 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.
  • Alanine Transaminase (ALT) >2x Upper Limit of Normal (ULN); and bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent). 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). Chronic stable hepatitis B and C (e.g., presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria.
  • Subjects with any of the following at Screening (Visit 1): 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 (NYHA) Class IV Heart failure.
  • Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit 1. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the Subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead ECG tracing that is interpreted at, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute (BPM); sustained and non-sustained ventricular tachycardia (VT); second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTc) >=500 millisecond (msec) in subjects with QRS <120 msec and QTc >=530 msec in subjects with QRS >=120 msec.
  • A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, 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 Investigator, contraindicates study participation.
  • Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the subject has been considered cured by treatment.
  • Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liters per minute (L/minute) (Oxygen use <=3 L/minute flow is not exclusionary.)
  • Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
  • Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Programme within 4 weeks prior to screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Programme during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Programme are not excluded.
  • Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
  • Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
  • Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
  • In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials.
  • Subjects taking following drug therapies will be excluded; subjects taking inhaled short-acting anticholinergics alone or along with short-acting beta agonist combination within 6 hours prior to screening; subjects taking inhaled short-acting beta2 agonists within >=4 hours prior to screening; subjects taking ICS, ICS/inhaled LABA combinations (e.g., FF/salmeterol, mometasone furoate/formoterol fumarate, budesonide/formoterol fumarate; FF/VI), Phosphodiesterase 4 (PDE4) inhibitors (roflumilast), LABA (e.g., indacaterol, olodaterol), LAMA (e.g., LAMA/LABA combinations UMEC, aclidinium, glycopyrronium), LAMA/LABA combinations, theophyllines, sodium cromoglycate and nedocromil sodium, anti-leukotrienes as maintenance treatment within 3 months prior to Visit 1 will be excluded. Maintenance treatment is defined as use for >=14 consecutive days (at any time in the 3 months prior to Visit 1). Subjects taking long term antibiotic therapy. (Antibiotics are allowed for the short term treatment (<=14 days) of an exacerbation or for short term treatment (<=14 days) of other acute infections during the study); subjects taking systemic, oral, parenteral corticosteroids 30 days prior to screening; (During the study oral/systemic corticosteroids may be used for <=14 days to treat COPD exacerbations/pneumonia) will be excluded. Intra-articular injections are allowed; subjects taking any other investigational drug within 30 days or 5 half-lives whichever is longer prior to screening will be excluded.

Trial locations and contacts

72 sites in 3 countries.

72 sites in 3 countries

United States33 sites

  • GSK Investigational Site

    Andalusia, Alabama, 36420

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Bronxville, New York, 10708

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Dublin, Ohio, 43016

  • GSK Investigational Site

    DuBois, Pennsylvania, 15801

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Fayetteville, New York, 13066

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Greer, South Carolina, 29650

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Huntsville, Texas, 77340

  • GSK Investigational Site

    Kissimmee, Florida, 34741

  • GSK Investigational Site

    Little River, South Carolina, 029566

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33134

  • GSK Investigational Site

    Miami Lakes, Florida, 33014

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407

  • GSK Investigational Site

    Nampa, Idaho, 83687

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Oxon Hill, Maryland, 20745

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Pelzer, South Carolina, 29669

  • GSK Investigational Site

    Sacramento, California, 95821

  • GSK Investigational Site

    Salt Lake City, Utah, 84102

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Simi Valley, California, 93065

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

Other trials in United States

Poland25 sites

  • GSK Investigational Site

    Bialystok, 15-003

  • GSK Investigational Site

    Bialystok, 15-044

  • GSK Investigational Site

    Bielsko-Biala, 43-300

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Bydgoszcz, 85-863

  • GSK Investigational Site

    Chojnice, 89-600

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Kielce, 25-751

  • GSK Investigational Site

    Krakow, 30-033

  • GSK Investigational Site

    Krakow, 31-209

  • GSK Investigational Site

    Lublin, 20-412

  • GSK Investigational Site

    Nowa Sól, 67-100

  • GSK Investigational Site

    Ostróda, 14-100

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400

  • GSK Investigational Site

    Piaseczno, 05-500

  • GSK Investigational Site

    Proszowice, 32-100

  • GSK Investigational Site

    Siedlce, 08-110

  • GSK Investigational Site

    Skierniewice, 96-100

  • GSK Investigational Site

    Sopot, 81-741

  • GSK Investigational Site

    Swidnica, 58-100

  • GSK Investigational Site

    Szczecin, 71-124

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Warsaw, 02-777

  • GSK Investigational Site

    Zamość, 22-400

  • GSK Investigational Site

    Zawadzkie, 47-120

Other trials in Poland

Russia14 sites

  • GSK Investigational Site

    Ivanovo, 153005

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 115682

  • GSK Investigational Site

    Novosibirsk, 630008

  • GSK Investigational Site

    Novosibirsk, 630087

  • GSK Investigational Site

    Saint Petersburg, 196084

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saint Petersburg, 199106

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

About this study

Official title: A Phase IV, 12 Week, Randomised, Double-blind, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.

Being tested
FF/UMEC/VI, Tiotropium, Albuterol/salbutamol, Placebo to match FF/UMEC/VI, Placebo to match tiotropium
Keywords
Umeclidinium, Lung function, RESPIMAT, Chronic obstructive pulmonary disease, Triple Therapy, Vilanterol, HANDIHALER, Tiotropium, Fluticasone furoate
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.

  • FF/UMEC/VIDrug

    A single inhaler triple therapy of FF/UMEC/VI will be provided via ELLIPTA DPI. FF/UMEC/VI will be available as dry white powder with dosing strengths of 100/25/62.5 mcg per blister.

  • TiotropiumDrug

    Tiotropium will be provided as a hard gelatin capsule for oral inhalation containing 18 mcg tiotropium bromide blended with lactose, administered via HANDIHALER DPI.

  • Albuterol/salbutamolDrug

    Albuterol/salbutamol will be provided as an inhalation via MDI with a spacer or nebules and will be given as a rescue medication throughout the study.

  • Placebo to match FF/UMEC/VIDrug

    Placebo matching FF/UMEC/VI will be available as a dry white powder of lactose or magnesium stearate, administered via ELLIPTA DPI.

  • Placebo to match tiotropiumDrug

    Placebo will be given as hard gelatin capsule for oral inhalation containing lactose, administered via HANDIHALER DPI.

  • ELLIPTA inhalerDevice

    ELLIPTA DPI will contain two individual blister strips with 30 blisters per strip. FF/UMEC/VI and placebo to match FF/UMEC/VI will be administered to the subjects using ELLIPTA DPI.

  • HANDIHALERDevice

    Tiotropium and placebo to match tiotropium will be administered to the subjects using HANDIHALER DPI.

  • MDIDevice

    Albuterol/salbutamol will be provided as a rescue medication throughout the study using MDI.

Study groups in NCT03474081
Study groupRoleWhat they receive
Subjects receiving FF/UMEC/VI + Placebo to match tiotropiumExperimentalEligible subjects will receive FF/UMEC/VI at a dose of 100/62.5/25 microgram (mcg) administered once daily in the morning via ELLIPTA along with placebo to match tiotropium administered once daily in the morning via HANDIHALER. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via metered dose inhaler (MDI).
Receives: Drug: FF/UMEC/VI; Drug: Albuterol/salbutamol; Drug: Placebo to match tiotropium; Device: ELLIPTA inhaler; Device: HANDIHALER; Device: MDI
Subjects receiving Tiotropium + Placebo to match FF/UMEC/VIExperimentalEligible subjects will receive Tiotropium at a dose of 18 mcg administered once daily in the morning via HANDIHALER along with placebo to match FF/UMEC/VI administered once daily in the morning via ELLIPTA. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via MDI.
Receives: Drug: Tiotropium; Drug: Albuterol/salbutamol; Drug: Placebo to match FF/UMEC/VI; Device: ELLIPTA inhaler; Device: HANDIHALER; Device: MDI

What is being measured

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

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 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 Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.

    Measured: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 85

Secondary outcomes (5)

  1. Change From Baseline in Trough FEV1 on Day 28

    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 Day 28 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 28. Change from Baseline in trough FEV1 on Day 28 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 28. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.

    Measured: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 28

  2. Change From Baseline in Trough FEV1 on 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. Trough FEV1 on Day 84 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 84. Change from Baseline in trough FEV1 on Day 84 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 84. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.

    Measured: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 84

  3. Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement was categorized as SAE.

    Measured: Up to Day 95

  4. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose) and Day 84

  5. Change From Baseline in Pulse Rate

    Pulse rate was assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose) and Day 84

Timeline

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

  1. First posted22 Mar 2018
  2. Study start29 Mar 2018
  3. Primary completion17 Jul 2019
  4. Study completion17 Jul 2019

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
Parallel groups
Model description
Subjects will be randomized 1:1 to receive either FF/UMEC/VI via ELLIPTA DPI along with placebo to match tiotropium or tiotropium via HANDIHALER along with placebo to match FF/UMEC/VI in the morning for 84 days.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474081
Sponsor's protocol ID
207626
Other IDs
2017-001190-16, 2017
Status last verified
Jul 2021
First submitted
15 Mar 2018
Last updated
15 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site

Publications

  • Bansal S, Anderson M, Anzueto A, Brown N, Compton C, Corbridge TC, Erb D, Harvey C, Kaisermann MC, Kaye M, Lipson DA, Martin N, Zhu CQ, Papi A. Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD. NPJ Prim Care Respir Med. 2021 May 25;31(1):29. doi: 10.1038/s41533-021-00241-z.

    PubMed 34035312

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FF/UMEC/VI, Tiotropium and Albuterol/salbutamol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 sites in 3 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 9 inclusion and 24 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 15 Jul 2021. 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 United States, Poland, Russia. 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 24 Apr 2020). 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 Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 85 (time frame: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) 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 NCT03474081, 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 15 Jul 2021.

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