Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; GSK233705/GW642444
Intervention description: matching placebo; The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; long-acting beta agonist; Emphysema; Chronic Bronchitis; Chronic Obstructive Pulmonary Disease (COPD); bronchodilator; long acting muscarinic antagonist

Summary:

      The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the
      combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and females 40 to 80 years of age (inclusive)

          -  COPD diagnosis

          -  Current or previous smokers with a cigarette smoking history of at least 10 pack-

          -  Post-albuterol FEV1/FVC of 0.70 or less

          -  Post-albuterol FEV1 of 35% to 80% (inclusive)

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  current diagnosis of asthma

          -  respiratory disorders other than COPD

          -  clinically significant cardiovascular, neurological, psychiatric, renal,
             immunological, endocrine, or hematological abnormalities that are uncontrolled

          -  clinically significant sleep apnea

          -  previous lung resection surgery

          -  clinically significant abnormalities confirmed by chest x-ray that are not related to
             COPD

          -  hospitalization for COPD within 3 months of screening

          -  use of antibiotics for lower respiratory tract infection within 6 months of screening

          -  abnormal and clinically significant 12-lead ECG findings

          -  current malignancy in remission for less that 5 years

          -  medical conditions that would contraindicate the use of anticholinergics

          -  positive hepatitis B or C test

          -  history of alcohol or drug abuse

          -  unable to withhold albuterol for 6 or more hours

          -  use of long term oxygen therapy

          -  conditions that would limit the validity of informed consent

          -  use of GW642444 or GSK233705 in previous studies

          -  use of an investigation drug with 30 days of screening

          -  use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone
             propionate or equivalent

          -  hypersensitivity to beta-agonists

          -  concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring
             antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot
             corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators,
             inhaled short acting anticholinergics.