Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: FF; UMEC; VI
Intervention description: 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); 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); 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)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GSK573719; asthma; UMEC; FF; GSK2829332; persistent obstruction; GW685698; Fluticasone Furoate; COPD; umeclidinium bromide

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 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