INCLUSION CRITERIA
age 40 years to 80 years
boolean
As per the GOLD definition [GOLD, 2003] which defines COPD as characterised by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
boolean
informed consent
boolean
post-bronchodilator FEV1
boolean
post bronchodilator FEV/FVC ratio
boolean
Values of 10.1 to 10.4% will be rounded down to 10%; values of 10.5 to 10.9% will be rounded up to 11%.
boolean
10 pack years is defined as 20 cigarettes (or equivalent if subject smoked cigars or a pipe) per day for 10 years, or 10 cigarettes per day for 20 years). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Smokers who have stopped smoking less than 6 months before Visit 1 will be defined as current smokers.
boolean
score of at least 2 on Modified Medical Research Council Dyspnoea Scale
boolean
i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal
boolean
Acceptable methods of contraception are: • complete abstinence from intercourse for the duration of the study • male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject • implants of levo-norgestrol • injectable progestogen • oral contraceptive (either combined or progestogen only) • any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year • any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year • barrier method only if used in combination with any of the above acceptable methods
boolean
EXCLUSION CRITERIA
COPD exaceration requiring therapy
boolean
current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis
boolean
e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis
boolean
e.g., lung transplant and/or lung volume reduction
boolean
chest Xray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months
boolean
breastfeeding
boolean
LTOT is defined as ≥ 12 hours oxygen use per day with resting pO2 below 7.3 kPa.
boolean
except eye drops
boolean
serious, uncontrolled disease
boolean
change in COPD medication
boolean
pulmonary rehabilitation
boolean
respiratory tract infection requiring antibiotics and/or hospitalization
boolean
receiving tiotropium bromide, inhaled corticosteroids or anti-leukotrienes
boolean
oral/parenteral corticosteroids
boolean
other investigational drugs
boolean
medications inhibiting cytochrome P450 CYP3A4
boolean
substance abuse
boolean
hypersensitivity to ß2 -agonists, inhaled steroids or lactose
boolean
belongs to reasearch personnel
boolean
previously enrolled to this study
boolean