Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Of non-childbearing potential.
Diagnosed with COPD, as defined by the GOLD guidelines.
Smoker or an ex-smoker with a smoking history of at least 10 pack years.
FEV1/FVC \< 0.7 post-bronchodilator (salbutamol).
FEV1 \<= 80% of predicted normal for height, age and gender after inhalation of salbutamol.
Response to ipratropium bromide 9.
Subject's weight is 60kg.
You may not be if
Past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
FEV1 \<=50% of predicted after inhalation of salbutamol.
Tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
Has claustrophobia that may be aggravated by entering the plethysmography cabinet.
Has prostate hypertrophy or narrow angle glaucoma.
Diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, or asthma.
Poorly controlled COPD.
Participated in a Pulmonary Rehabilitation Program within 4 weeks prior to screening visit or will enter a program during the study.
Had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
History of congestive heart failure, coronary insufficiency or cardiac arrhythmia.
A mean QTc(B) value at screening \>440msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120-210msec or an ECG that is not suitable for QT measurements.
A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg.
A mean heart rate outside the range 40-90 bpm.
QTc prolongation \>470msec or risk factors for torsades de pointes (heart failure NYHA II-IV, hypokalaemia, familial long QT syndrome).
Receiving co-medication with drugs which prolong the QTc interval.
Requires treatment with inhaled cromolyn sodium or nedocromil, oral beta-2-agonists, nebulised beta-2-agonists, nebulised anticholinergics or leukotriene modifiers.
Unable to abstain from xanthines (other than caffeine.
Unable to abstain from short-acting inhaled bronchodilators.
Unable to abstain from long-acting inhaled bronchodilators.
Changed dose of inhaled or oral corticosteroids within the last 6 weeks.
Taking more than 10mg/day of prednisolone (or equivalent).
Receiving treatment with long term or short-term oxygen therapy or requires nocturnal positive pressure for sleep apnea.
Clareo Health | Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
