MedDataX Logo

Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

NCT ID: NCT02164539

Last Updated: 2017-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2015-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

GSK573719 asthma UMEC FF GSK2829332 persistent obstruction GW685698 Fluticasone Furoate COPD umeclidinium bromide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Phase A

Eligible subjects will enter a 4-week run-in period and will receive fluticasone propionate/salmeterol. Subjects will then be randomized to receive fluticasone furoate 100 mcg, fluticasone furoate/umeclidinium bromide 100/15.6 mcg, fluticasone furoate/umeclidinium bromide 100/62.5 mcg, fluticasone furoate/umeclidinium bromide 100/125 mcg, fluticasone furoate/umeclidinium bromide 100/250 mcg, or fluticasone furoate/vilanterol 100/25 mcg, respectively for 4 weeks

Group Type EXPERIMENTAL

FF

Intervention Type DRUG

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

UMEC

Intervention Type DRUG

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

VI

Intervention Type DRUG

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Treatment Phase B

Subjects completing Treatment Phase A will be randomized to receive either fluticasone furoate/umeclidinium bromide100/250 mcg or fluticasone furoate/umeclidinium bromide/vilanterol 100/250/25 mcg for 1 week.

Group Type EXPERIMENTAL

FF

Intervention Type DRUG

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

UMEC

Intervention Type DRUG

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

VI

Intervention Type DRUG

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Treatment Phase C

Subjects completing Treatment Phase B will be randomized to receive either the same treatment as in Treatment Phase B, or the same treatment minus the umeclidinium bromide component, for 1 week.

Group Type EXPERIMENTAL

FF

Intervention Type DRUG

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

UMEC

Intervention Type DRUG

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

VI

Intervention Type DRUG

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FF

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Intervention Type DRUG

UMEC

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

Intervention Type DRUG

VI

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older
* COPD with evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at screening as follows:

* Post-bronchodilator morning (AM) FEV1 \>=50% and \<=80% of the predicted normal value at Visit 1
* Pre- and post-bronchodilator FEV1/FVC ratio \<0.7.
* Demonstrated reversibility by \>=12% and \>=200 mL increase in FEV1 following albuterol at Visit 1.
* A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist or leukotriene modifier, etc.) for a minimum of 12 weeks prior to Visit 1.
* Outpatient subjects who are smokers or non-smokers.

Exclusion Criteria

* History of life-threatening respiratory event within the last 5 years.
* Unresolved respiratory infection
* Recent Severe COPD or Asthma Exacerbation
* Risk factors for pneumonia
* Hospitalization for pneumonia within 3 months
* Concurrent respiratory disease other than chronic obstructive pulmonary disease or asthma.
* Other uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
* Viral hepatitis or HIV
* Current or chronic history of liver disease, known hepatic or biliary abnormalities
* Drug or milk protein allergy
* Administration of prescription or over-the-counter medication that would significantly affect the course of COPD or asthma, or interact with study drug
* Subjects with lung volume reduction surgery within 12 months prior to screening.
* Use of long-term oxygen therapy (LTOT)
* Requirement for nebulized therapy
* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
* Unstable or life-threatening cardiac disease
* Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding
* Diseases preventing the use of anticholinergics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Upland, California, United States

Site Status

GSK Investigational Site

Sunset, Louisiana, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

Charlotte, North Carolina, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Gaffney, South Carolina, United States

Site Status

GSK Investigational Site

Greenville, South Carolina, United States

Site Status

GSK Investigational Site

Rock Hill, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Union, South Carolina, United States

Site Status

GSK Investigational Site

Morgantown, West Virginia, United States

Site Status

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

San Rafael, Mendoza Province, Argentina

Site Status

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Leipzg, Saxony, Germany

Site Status

GSK Investigational Site

Teuchern, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Kielce, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Sopot, , Poland

Site Status

GSK Investigational Site

Zgierz, , Poland

Site Status

GSK Investigational Site

Żnin, , Poland

Site Status

GSK Investigational Site

Bacau, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Cluj-Napoca, , Romania

Site Status

GSK Investigational Site

Comuna Alexandru Cel Bun, , Romania

Site Status

GSK Investigational Site

Craiova, , Romania

Site Status

GSK Investigational Site

Piteşti, , Romania

Site Status

GSK Investigational Site

Ploieşti, , Romania

Site Status

GSK Investigational Site

Ploieşti, , Romania

Site Status

GSK Investigational Site

Timișoara, , Romania

Site Status

GSK Investigational Site

Blagoveshchensk, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Nizhny Novgorod, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saratov, , Russia

Site Status

GSK Investigational Site

Sestroretsk, , Russia

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Germany Poland Romania Russia Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

Lee L, Kerwin E, Collison K, Nelsen L, Wu W, Yang S, Pascoe S. The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. Respir Med. 2017 Oct;131:148-157. doi: 10.1016/j.rmed.2017.08.013. Epub 2017 Aug 14.

Reference Type DERIVED
PMID: 28947022 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200699

Identifier Type: -

Identifier Source: org_study_id