Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease

Inclusion Criteria

• Type of subject: Outpatient.
• Informed Consent: Capable of giving signed informed consent, which includes compliance with pre-specified requirements and restrictions.
• Age and gender: Male and female subjects, 40 years of age or older at the time of signing the informed consent, are eligible to participate in the study.

Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:

• Non-reproductive potential defined as:

Pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

• Reproductive potential and agrees to follow one of the options listed below 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit. This list does not apply to females of reproductive potential with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis:

Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a =30 and = = 10 pack-years at Visit 1. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.

Number of pack years = (number of cigarettes per day / 20) x number of years smoked (for example, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years).

Note: Pipe and cigar use cannot be used to calculate pack-year history.

Exclusion Criteria

• Asthma: A current diagnosis of asthma (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
• Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. Other excluded conditions include and not limited to clinically significant bronchiectasis, pulmonary hypertension unrelated to COPD, sarcoidosis, or interstitial lung disease. Or a subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD
• Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for =110 bpm (Note: Sinus tachycardia >=110 should be confirmed by two additional readings at least 5 minutes apart) Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100 bpm) PR interval >240 milliseconds (msec) Evidence of Mobitz II second degree or third degree atrioventricular (AV) block Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolt (mV) (4 millimeters [mm] with 10 mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5 mV [5 mm with 10 mm/mV setting], appearing in at least two contiguous leads (Note: prior evidence [that is, ECG obtained at least 12 months prior) of pathological