study to evaluate safety and tolerability of gsk256066 in chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will evaluate the safety and tolerability of the cfor the first time in mild to moderate copd patients.


Eligibility criteria:
inclusion criteria: * male adults or female adults of non-childbearing potential who are between 40 and 75 years of age (inclusive). * subjects with a clinical diagnosis of copd in accordance with the european respiratory society consensus statement and subjects categorised with moderate copd as defined by the gold guidelines of 2006 \[gold, 2006\] * subjects with a cigarette smoking history of ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or the equivalent). both current and former smokers are eligible to be enrolled. a former smoker is defined as a subject who has not smoked for ≥6 months at visit 1. * subjects with a post-bronchodilator fev1 to fvc ratio (fev1/fvc) \< 0.7 at visit 1. subjects will be assessed 30 (± 5) minutes after receiving salbutamol 400 μg. * subjects with a post-bronchodilator fev1 ≥ 50% and \< 80% of predicted normal for height, age and sex at visit 1. subjects will be assessed 30 (± 5) minutes after receiving salbutamol 400 μg. * subjects with a normal echocardiogram at screening, as defined by the absence of clinically significant wall motion, chamber size or valvular abnormalities * the subject must be capable of giving informed consent and can comply with the study requirements and timetable. exclusion criteria: * women who are pre-menopausal and of child-bearing potential. * subjects weighing less than 50 kilograms (kg). * subjects who are obese defined as having a body mass index (bmi) \> 30. * subjects with a current diagnosis of asthma. * subjects who have required hospitalisation or treatment with oral corticosteroids and/or antibiotic therapy for acute worsening of copd or lower respiratory tract infection in the 6 weeks prior to screening. * subjects who have received treatment with oral, intravenous, topical or intra-articular corticosteroids within 6 weeks of screening or thereafter * subjects with active tuberculosis, sarcoidosis or clinically overt bronchiectasis. * subjects with a history of any type of malignancy with the exception of successfully treated squamous cell cancer of the skin. * subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. inflammatory bowel disease). * subjects with chronic infections (lasting longer than 6 months) such as gingivitis, periodontitis, prostatitis, gastritis, and urinary tract infections. * subjects with any acute infection, sinus symptoms, or significant trauma (burns, fractures). * subjects with clinically significant renal disease, diabetes mellitus/metabolic syndrome, hypertension or any other clinically significant cardiovascular, neurological, endocrine, or haematological abnormalities that are uncontrolled on permitted therapy. * subjects who have participated in any gsk study/studies involving administration of coa. * the subject has a screening ecg parameters outside of ranges specified in protocol. * subjects with hypoxaemia * risk factors for human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection at screening (visit 1). * subjects who have undergone surgery including lung volume reduction surgery in the last six months or have conditions that prevent them from performing spirometry. * subjects with a history (or suspected history) of alcohol misuse or any other recreational substance abuse. * subjects who require treatment with any of the following from the start of the run-in period (day -14) until the end of the treatment phase: * inhaled corticosteroids * inhaled cromolyn sodium or nedocromil * xanthines (theophylline preparations). * leukotriene modifiers * tiotropium * long-acting inhaled beta2-agonists (salmeterol, formoterol) * oral beta2-agonists * subjects who are unable to abstain from other courses of medication during the run in phase including non-steroidal anti-inflammatory drugs (nsaids), anti-depressant drugs, anti-histamines, anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists, ipratropium bromide and paracetamol (up to 4 g per day) for the treatment of minor ailments (eg headache) from 48h before the first dose until the follow-up visit. subjects requiring medication between dosing and follow up may be excluded at the principal investigators discretion. * subjects with any known hypersensitivity to salbutamol or ipratropium bromide. * subjects who are participating or plan to participate in the active phase of a pulmonary rehabilitation programme during the study. * subjects who have received an investigational drug within 30 days or within five drug half-lives of the investigational drug (whichever is longer). * subjects with any clinically relevant abnormality detected by the assessments at screening. * subjects who have experienced an exacerbation during the run-in period requiring treatment with oral corticosteroids and/or macrolide antibiotics and/or hospitalisation.

Keywords: chronic obstructive pulmonary disease (copd) copd repeat dose gsk256066