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

NCT01777334 | Completed Phase 3 Results

• 1 other identifier: 117115
• Study Type: interventional
• Target: 905
• Locations: 9 countries
• Sites: 70

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (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.

  Baseline and Day 169

Secondary Outcomes (1)

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

  Baseline and Day 168

Study Arms (2)

Umeclidinium/Vilanterol

EXPERIMENTAL

Long-acting muscarinic antagonist (LAMA)/Long-acting Beta agonist (LABA)

Drug: Umeclidinium/Vilanterol 62.5/25 mcg

Tiotropium

ACTIVE COMPARATOR

Long-acting muscarinic antagonist (LAMA)

Drug: Tiotropium 18 mcg

Interventions

Umeclidinium/Vilanterol 62.5/25 mcg DRUG

Inhalation Powder

Umeclidinium/Vilanterol

Tiotropium 18 mcg DRUG

Inhalation Powder

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Asthma: A current diagnosis of asthma.
• 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.
• Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
• 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).
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (70)

GSK Investigational Site

Tucson, Arizona, 85723, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

San Diego, California, 92103-8415, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Panama City, Florida, 32405, United States

Location

GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Columbus, Ohio, 43215, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Easley, South Carolina, 29640, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37601, United States

Location

GSK Investigational Site

Ciudad Autnónoma de Buenos Aires, Buenos Aires, C1186ACB, Argentina

Location

GSK Investigational Site

Dimitrovgrad, 6400, Bulgaria

Location

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Plovdiv, 4002, Bulgaria

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Stara Zagora, 6003, Bulgaria

Location

GSK Investigational Site

Troyan Municipality, 5600, Bulgaria

Location

GSK Investigational Site

Varna, 9000, Bulgaria

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 4E1, Canada

Location

GSK Investigational Site

Moncton, New Brunswick, E1G1A7, Canada

Location

GSK Investigational Site

Burlington, Ontario, L7N 3V2, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8L 5G8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3H 5S4, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1N8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2R 1V6, Canada

Location

GSK Investigational Site

Québec, Quebec, G3K 2P8, Canada

Location

GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Neu-Isenburg, Hesse, 63263, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04275, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Berlin, 10119, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Hamburg, 20354, Germany

Location

GSK Investigational Site

Balassagyarmat, 2660, Hungary

Location

GSK Investigational Site

Budaörs, 2040, Hungary

Location

GSK Investigational Site

Debrecen, 4032, Hungary

Location

GSK Investigational Site

Gödöllő, 2100, Hungary

Location

GSK Investigational Site

Nyíregyháza, 4400, Hungary

Location

GSK Investigational Site

Szikszó, 3800, Hungary

Location

GSK Investigational Site

Bucharest, 020125, Romania

Location

GSK Investigational Site

Bucharest, 050159, Romania

Location

GSK Investigational Site

Bucharest, 70000, Romania

Location

GSK Investigational Site

Cluj-Napoca, 400371, Romania

Location

GSK Investigational Site

Codlea, 505100, Romania

Location

GSK Investigational Site

Deva, 330084, Romania

Location

GSK Investigational Site

Barnaul, 656 045, Russia

Location

GSK Investigational Site

Belgorod, 308007, Russia

Location

GSK Investigational Site

Krasnodar, 350012, Russia

Location

GSK Investigational Site

Moscow, 119002, Russia

Location

GSK Investigational Site

Moscow, 123367, Russia

Location

GSK Investigational Site

Pyatigorsk, 357538, Russia

Location

GSK Investigational Site

Saint Petersburg, 194354, Russia

Location

GSK Investigational Site

Saint Petersburg, 198260, Russia

Location

GSK Investigational Site

Alicante, 03004, Spain

Location

GSK Investigational Site

Mérida (Badajoz), 06800, Spain

Location

GSK Investigational Site

Salt (gerona), 17190, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 27796912 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719; vilanterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: January 23, 2013
• Primary Completion: September 24, 2013
• Study Completion: September 24, 2013
• Last Updated: January 24, 2018
• Results First Posted: June 5, 2014

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

RU (8); AR (1); HU (6); CA (11); BU (7); US (17); DE (10); RO (6); ES (4)