Clinical trial NCT01316913 (phase 3, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: gsk573719/gw642444 125/25, gsk573719/gw642444 62.5/25, gsk573719, tiotropium bromide
SMILES: OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl, [H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1
Eligibility criteria:

        Inclusion Criteria:

          -  outpatient

          -  signed and dated written informed consent

          -  40 years of age or older

          -  male and female subjects

          -  COPD diagnosis

          -  at least 10 pack-year smoking history

          -  post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1
             of less than or equal to 70% predicted normal values

          -  score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea
             Scale (mMRC)

        Exclusion Criteria:

          -  women who are pregnant or lactating or are planning on becoming pregnant during the
             study

          -  current diagnosis of asthma

          -  other respiratory disorders other than COPD

          -  other diseases/abnormalities that are uncontrolled including cancer not in remission
             for at least 5 years

          -  chest x-ray or CT scan with clinically significant abnormalities not believed to be
             due to COPD

          -  hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium
             stearate or medical conditions associated with inhaled anticholinergics

          -  hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1

          -  lung volume reduction surgery within 12 months prior to Visit 1

          -  abnormal and clinically significant ECG at Visit 1

          -  significantly abnormal finding from laboratory tests at Visit 1

          -  unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each
             visit

          -  use of depot corticosteroids within 12 weeks of Visit 1

          -  use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract
             infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1

          -  use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if
             LABA/ICS therapy is discontinued withing 30 days of Visit 1

          -  use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30
             days of Visit 1

          -  initiation or discontinuation of ICS within 30 days of Visit 1

          -  use of tiotropium or roflumilast within 14 days of Visit 1

          -  use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or
             inhaled long-acting beta-agonists within 48 hours of Visit 1

          -  short-acting oral beta-agonists within 12 hours of Visit 1

          -  use of LABA/ICS combination products only if discontinuing LABA therapy and switching
             to ICS monotherapy within 48 hours of Visit 1 for the LABA component

          -  use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1

          -  use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or
             inhaled short-acting anticholinergic/short-acting beta-agonist combination products
             within 4 hours of Visit 1

          -  use of any other investigational medication within 30 days or 5 drug half-lives
             (whichever is longer)

          -  long-term oxygen therapy prescribed for >12 hours per day

          -  regular use of nebulized short-acting bronchodilators

          -  participation in acute phase of pulmonary rehabilitation program

          -  known or suspected history of alcohol or drug abse within 2 years prior to Visit 1

          -  anyone affiliated with the investigator site (e.g., investigator, sub-investigator,
             study coordinator, employee of a participating investigator or study site, or
             immediate family member)

          -  previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol),
             or fluticasone furoate/GW642444 combination