Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: FF/GSK573719; FF/GSK573719; FF/GSK573719; FF/GSK573719; FF/GSK573719; FF; FF/VI
Intervention description: 100/15.6; 100/31.25; 100/62.5; 100/125; 100/250; 100; 100/25
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fluticasone Furoate; Vilanterol; Adults; GSK573719; Asthma

Summary:

      Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in
      combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled
      Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

      Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic
      bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms
      on large and small airways. Most of the experience with older anti-cholinergics had been with
      acute use and little is known about their effect in chronic use in asthma. This is a
      multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled
      GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and
      Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each
      eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3
      treatment periods per subject. The total duration of subject participation is approximately
      14 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient

          -  18 years of age or older at Visit 1

          -  Diagnosis of Asthma

          -  Male or eligible Female

          -  Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1

          -  Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes 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 8 weeks prior to Visit 1.

        Exclusion Criteria:

          -  History of Life threatening asthma

          -  Respiratory infection not resolved

          -  Asthma exacerbation

          -  Concurrent respiratory disease

          -  Current Smokers

          -  Other diseases that are uncontrolled disease or disease state that, in the opinion of
             the investigator, would put the safety of the patient at risk through study
             participation or would confound the interpretation of the efficacy results if the
             condition/disease exacerbated during the study

          -  A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV

          -  Visual clinical evidence of oropharyngeal candidiasis

          -  Drug or milk protein allergies

          -  Concomitant medications affecting course of asthma

          -  Use of any other investigational medication within 30 days or 5 drug half-lives
             (whichever is longer)

          -  Previous use of GSK573719

          -  Any disease preventing use of anticholinergics

          -  Any condition that impairs compliance with study protocol including visit schedule and
             completion of daily diaries

          -  Any subject with a history of alcohol or substance abuse

          -  Any affiliation with Investigator's site