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:
• •1. 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.
• •2. 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 \<1% rate of failure per year, as stated in the product label Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a \<1% rate of failure per year, as stated in the product label Oral Contraceptive, either combined or progestogen alone Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
• •Chronic Obstructive Pulmonary Disease (COPD): An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
• •COPD Disease severity: A post-albuterol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of =\<0.70 and a post-albuterol FEV1 \>=30 and =\<80% of predicted normal values calculated using the European Respiratory Society Global Lung Function Initiative reference equations at Visit 1.
• +27 more criteria