A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.

Key facts

Study ID

NCT01372410

Run by

GlaxoSmithKline

People needed

163

Starts

2011-07-01

Expected to finish

2011-10-27

Last updated by the study team

2017-11-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Costa Mesa, California, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Duluth, Georgia, United States
• GSK Investigational Site — Edina, Minnesota, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Easley, South Carolina, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States

Full record on ClinicalTrials.gov

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