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

Completed · Phase 2

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT02164539

Run by

GlaxoSmithKline

People needed

338

Starts

2014-07-01

Expected to finish

2015-07-18

Last updated by the study team

2017-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Rock Hill, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Morgantown, West Virginia, United States
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — San Rafael, Mendoza Province, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Tucumán Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Mendoza, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Neu-Isenburg, Hesse, Germany
• GSK Investigational Site — Newport Beach, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.