Clinical trial NCT01372410 (phase 2, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: gsk573719, gsk573719, gsk573719, gsk573719, gsk573719, gsk573719, tiotropium, placebo
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, 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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient

          -  A signed and dated written informed consent prior to study participation.

          -  Male or female adults.

          -  40 to 80 years of age at Visit 1

          -  Diagnosis of COPD

          -  Current or former cigarette smokers with a history of cigarette smoking of greater
             than or equal to 10 pack-years

          -  Post-albuterol forced expiratory volume in 1 second (FEV1)/ forced vital capacity
             (FVC)<0.70 and post albuterol FEV1 of greater than or equal to 35% and less than or
             equal to 70% of predicted normal values

        Exclusion Criteria:

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

          -  A current diagnosis of asthma

          -  Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis),
             and lung cancer

          -  Other significant respiratory conditions in addition to COPD

          -  Other diseases that are uncontrolled including cancer in remission for less than 5
             years

          -  Chest x-ray or CT scan with clinically significant abnormalities not believed to be
             due to the presence of COPD

          -  Hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist,
             lactose/milk protein or magnesium stearate

          -  A medical condition that contraindicates study participation or use of an inhaled
             anticholinergic

          -  Hospitalization for COPD or pneumonia within 12 weeks of Visit 1

          -  Any previous lung resection surgery

          -  A body mass index (BMI) value of >35 kilogram (kg)/meter squared (m2)

          -  An abnormal and significant electrocardiogram finding at Visit 1

          -  Significantly abnormal finding from clinical chemistry or haematology tests at Visit
             1.

          -  A positive Hepatitis B surface antigen or positive Hepatitis C antibody

          -  Medically unable to withhold albuterol (salbutamol) for the 6 hour period prior to
             study visits

          -  Use of depot corticosteroids within 12 weeks of Visit 1

          -  Use of oral or parenteral corticosteroids or antibiotics for lower respiratory tract
             infection within 6 weeks of Visit 1

          -  Use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if
             LABA/ICS therapy is discontinued within 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 phosphodiesterase 4 inhibitors 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 6 hours of Visit 1

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

          -  Oxygen therapy prescribed for greater than 12 hours a day

          -  Regular use (prescribed for use every day, not for as-needed use) of short-acting
             bronchodilators

          -  Use of continuous positive airway pressure (CPAP), nocturnal positive pressure or
             non-invasive positive pressure ventilation (NIPPV), including use for sleep apnea.

          -  Acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

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

          -  Anyone affiliated with investigator site

          -  Previous use of GSK573719 or GSK53719/GW642444