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COMPLETEDPHASE2

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

200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

NCT02164539•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (67)

GSK Investigational Site

Newport Beach, California, United States

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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

July 18, 2015

Last Updated

October 11, 2017

Enrollment

338

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

UMEC

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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