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Pulmonary Disease, Chronic ObstructivePhase 3NCT01777334

The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD

A Phase 3 study testing Umeclidinium/Vilanterol 62.5/25 mcg and Tiotropium 18 mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 70 sites in 9 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 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments 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 62.5/25 mcg and Tiotropium 18 mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
905 participants
Where
70 sitesin 9 countries
Study dates
23 Jan 2013to 24 Sep 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). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy.
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  • OR
  • Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
  • Abstinence
  • Oral Contraceptive, either combined or progestogen alone
  • Injectable progestogen
  • Implants of levonorgestrel
  • Estrogenic vaginal ring
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records.
  • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].
  • 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.
  • Note: 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 FEV1 of <=70% of predicted normal values calculated using NHANES III reference equations at Visit 1 [Hankinson, 1999; Hankinson, 2010].
  • 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 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: A history of allergy or hypersensitivity to any 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 study physician contraindicates study participation or use of an inhaled anticholinergic.
  • Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
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  • Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
  • 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12-lead electrocardiogram (ECG) which causes the underlying rhythm and ECG to be obscured. 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.
  • Use of certain medications according to defined time intervals prior to Screening (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: 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.
  • Previous use of study drug: Previous participation in DB2113360 or DB2113374.

Trial locations and contacts

70 sites in 9 countries.

70 sites in 9 countries

United States17 sites

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

Canada11 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    Moncton, New Brunswick, E1G1A7

  • GSK Investigational Site

    Montreal, Quebec, H2R 1V6

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

Germany10 sites

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

Russia8 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Belgorod, 308007

  • GSK Investigational Site

    Krasnodar, 350012

  • GSK Investigational Site

    Moscow, 119002

  • GSK Investigational Site

    Moscow, 123367

  • GSK Investigational Site

    Pyatigorsk, 357538

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 198260

Other trials in Russia

Bulgaria7 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Stara Zagora, 6003

  • GSK Investigational Site

    Troyan Municipality, 5600

  • GSK Investigational Site

    Varna, 9000

Other trials in Bulgaria

Hungary6 sites

  • GSK Investigational Site

    Balassagyarmat, 2660

  • GSK Investigational Site

    Budaörs, 2040

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Nyíregyháza, 4400

  • GSK Investigational Site

    Szikszó, 3800

Other trials in Hungary

Romania6 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Bucharest, 70000

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Codlea, 505100

  • GSK Investigational Site

    Deva, 330084

Other trials in Romania

Spain4 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Mérida (Badajoz), 06800

  • GSK Investigational Site

    Salt (gerona), 17190

  • GSK Investigational Site

    Valencia, 46015

Other trials in Spain

Argentina1 site

  • GSK Investigational Site

    Ciudad Autnónoma de Buenos Aires, Buenos Aires, C1186ACB

Other trials in Argentina

About this study

Official title: A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.

Read the detailed description

This is a Phase IIIb multicenter, randomized, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25 mcg) when administered once-daily via a novel dry powder inhaler (DPI) compared with tiotropium (18 mcg) administered once-daily via the HandiHaler over a treatment period of 24 weeks in subjects with COPD. Eligible subjects will be randomized 1:1 to UMEC/VI Inhalation Powder (62.5/25 mcg), or tiotropium (18 mcg) for 24 weeks.

There will be a total of 10 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7- to 10-day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2 and after 4, 8, 12, 16, 20 and 24 weeks, and 1 day after the Week 24 visit (Visit 1 to Visit 10, respectively). Additionally a safety Follow-Up assessment will be conducted either by phone call or clinic visit where required approximately 7 days after the end of the study treatment (Visit 10 or Early Withdrawal, if applicable). The total duration of subject participation, including the Follow-Up will be approximately 26 weeks.

Being tested
Umeclidinium/Vilanterol 62.5/25 mcg, Tiotropium 18 mcg
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/Vilanterol 62.5/25 mcgDrug

    Inhalation Powder

  • Tiotropium 18 mcgDrug

    Inhalation Powder

Study groups in NCT01777334
Study groupRoleWhat they receive
Umeclidinium/VilanterolExperimentalLong-acting muscarinic antagonist (LAMA)/Long-acting Beta agonist (LABA)
Receives: Drug: Umeclidinium/Vilanterol 62.5/25 mcg
TiotropiumActive comparatorLong-acting muscarinic antagonist (LAMA)
Receives: Drug: Tiotropium 18 mcg

What is being measured

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

  1. Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)

    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 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.

    Measured: Baseline and Day 169

Secondary outcomes (1)

  1. Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168

    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 WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as the WM value at that visit minus the BL value. 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, center group, day, and day by BL and day by treatment interactions.

    Measured: Baseline and Day 168

Timeline

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

  1. First posted28 Jan 2013 (estimated)
  2. Study start23 Jan 2013
  3. Primary completion24 Sep 2013
  4. Study completion24 Sep 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
905 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01777334
Sponsor's protocol ID
117115
Status last verified
Jan 2018
First submitted
24 Jan 2013
Last updated
24 Jan 2018
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

  • Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naive Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. doi: 10.1007/s12325-016-0430-6. Epub 2016 Oct 28.

    PubMed 27796912

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umeclidinium/Vilanterol 62.5/25 mcg and Tiotropium 18 mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 70 sites in 9 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 22 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Canada, Germany, Russia, Bulgaria and 4 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 5 Jun 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 Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (time frame: Baseline and Day 169). 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 NCT01777334, 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 24 Jan 2018.

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