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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/13/2017
Start Date:July 1, 2014
End Date:July 18, 2015

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

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.


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
We found this trial at
15
sites
Charlotte, North Carolina 28203
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Ciudad Autonoma de Buenos Aires, Buenos Aires
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Ciudad Autonoma de Buenos Aires,
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Gaffney, South Carolina 29340
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Gaffney, SC
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Greenville, South Carolina 29615
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Greenville, SC
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Medford, Oregon 97504
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Medford, OR
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Morgantown, West Virginia 26506
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Morgantown, WV
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Newport Beach, California 92663
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Newport Beach, CA
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Rock Hill, South Carolina 29732
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Rock Hill, SC
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San Diego, California 92111
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San Diego, CA
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Sunset, Louisiana 70584
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Sunset, LA
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Union, South Carolina 29379
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Union, SC
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Upland, California 91786
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Upland, CA
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