Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:
Smoking history of at least 20 pack years
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted and \>or= 30% of predicted normal value
Post-bronchodilator FEV1/FVC \< 70%
("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)
You may not be if
Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
Patients requiring oxygen therapy for chronic hypoxemia (typically \>15h/day)
Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
Concomitant pulmonary disease
Asthma history (eosinophils \> 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
History of long QTc syndrome or QTc interval \> 450 ms for males and \>470 ms for females
Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
History of reactions to sympathomimetic amines or inhaled medication
Inability to use the dry powder devices or perform spirometry
Irregular day/night, wake/sleep cycles, e.g. shift workers
Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
Patients unable or unwilling to complete a patient diary
