Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring GSK573719, asthma, UMEC, FF, GSK2829332, persistent obstruction, GW685698, Fluticasone Furoate, COPD, umeclidinium bromide
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Treatment Phase A
Treatment Phase B
Treatment Phase C
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
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.
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.