The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium

NCT01899742 | Completed Phase 3 Results

• 1 other identifier: 116960
• Study Type: interventional
• Target: 497
• Locations: 10 countries
• Sites: 64

Brief Summary

The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8)

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label \[OL\] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.

  Baseline (BL) and Day 85

Secondary Outcomes (1)

• Change From BL in FEV1 at 3 Hours Postdose on Day 84

  Baseline and Day 84

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.
• Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)

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.
• Exacerbations: Has had more than 1 moderate or severe COPD exacerbation in the past 12 months. Subjects with a moderate exacerbation within 6 weeks or severe exacerbations within 10 weeks prior to Visit 1 are excluded from study.
• A moderate COPD exacerbation is defined as worsening symptoms of COPD that require treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that require in-patient hospitalization.
• 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.
• 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 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 3. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 3.
• Appendix 3:
• Sinus tachycardia ≥120 bpm. \*Note: sinus tachycardia ≥120bpm should be confirmed by two additional readings at least 5 minutes apart.
• Sinus bradycardia \<45bpm. \*Note: Sinus bradycardia \<45bpm should be confirmed by two additional readings at least 5 minutes apart.
• Multifocal atrial tachycardia.
• Supraventricular tachycardia (\>100bpm).
• Atrial fibrillation with rapid ventricular response (rate \>120bpm).
• Atrial flutter with rapid ventricular response (rate \>120bpm).
• Ventricular tachycardias (non sustained, sustained, polymorphic, or monomorphic).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (64)

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

La Plata, Buenos Aires, 1900, Argentina

Location

GSK Investigational Site

San Rafael, Mendoza Province, 5600, Argentina

Location

GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

Location

GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

Location

GSK Investigational Site

Mendoza, 5500, Argentina

Location

GSK Investigational Site

Mendoza, M5500CCG, Argentina

Location

GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 10138, Estonia

Location

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Tallinn, 13619, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Potsdam, Brandenburg, 14467, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14469, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30173, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

GSK Investigational Site

Düren, North Rhine-Westphalia, 52349, Germany

Location

GSK Investigational Site

Witten, North Rhine-Westphalia, 58452, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, 13581, Germany

Location

GSK Investigational Site

Bodø, 8005, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

GSK Investigational Site

Haugesund, 5528, Norway

Location

GSK Investigational Site

Kløfta, 2040, Norway

Location

GSK Investigational Site

Stavanger, 4005, Norway

Location

GSK Investigational Site

Tønsberg, 3116, Norway

Location

GSK Investigational Site

Blagoveshchensk, 675000, Russia

Location

GSK Investigational Site

Chelyabinsk, 454021, Russia

Location

GSK Investigational Site

Irkutsk, 664005, Russia

Location

GSK Investigational Site

Kemerovo, 650000, Russia

Location

GSK Investigational Site

Kemerovo, 650002, Russia

Location

GSK Investigational Site

Moscow, 125315, Russia

Location

GSK Investigational Site

Novosibirsk, 630102, Russia

Location

GSK Investigational Site

Saint Petersburg, 194356, Russia

Location

GSK Investigational Site

Bellville, 7530, South Africa

Location

GSK Investigational Site

Bloemfontein, 9301, South Africa

Location

GSK Investigational Site

Durban, 4001, South Africa

Location

GSK Investigational Site

Gatesville, 7764, South Africa

Location

GSK Investigational Site

Middelburg, 1501, South Africa

Location

GSK Investigational Site

Mowbray, 7700, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

Location

GSK Investigational Site

Gyeonggi-do, 410-719, South Korea

Location

GSK Investigational Site

Borås, SE-506 30, Sweden

Location

GSK Investigational Site

Gothenburg, SE-413 90, Sweden

Location

GSK Investigational Site

Luleå, SE-971 89, Sweden

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

GSK Investigational Site

Örebro, SE-703 62, Sweden

Location

GSK Investigational Site

Stockholm, SE-111 57, Sweden

Location

GSK Investigational Site

Kharkiv, 61124, Ukraine

Location

GSK Investigational Site

Kiev, 03680, Ukraine

Location

GSK Investigational Site

Kyiv, 03038, Ukraine

Location

GSK Investigational Site

Kyiv, 03049, Ukraine

Location

GSK Investigational Site

Kyiv, 03680, Ukraine

Location

GSK Investigational Site

Kyiv, Ukraine

Location

GSK Investigational Site

Mykolayiv, 54003, Ukraine

Location

GSK Investigational Site

Vinnytsia, 21001, Ukraine

Location

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: July 11, 2013
• First Posted: July 15, 2013
• Study Start: September 15, 2014
• Primary Completion: July 22, 2015
• Study Completion: July 22, 2015
• Last Updated: January 24, 2018
• Results First Posted: February 25, 2016

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (13); US (3); AR (7); KR (1); UA (8); SE (6); NO (6); ZA (7); RU (8); ES (5)