Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)

Exclusion Criteria

• •Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate \& visit can be scheduled upon resolution. If there is evidence at Baseline Visit, may be treated as appropriate \& visit can be rescheduled upon resolution.
• •History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) hypertension being treated with beta-blockers, active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB \[Fridericia or Bazett corrections, respectively \>500 milliseconds (msecs)\]), stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled \& stable (eg hypertension not requiring beta-blockers) will not prohibit participation if deemed appropriate per investigator.
• •Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients.
• •Female who is breast-feeding, pregnant, or intends to become pregnant.
• •Illicit drug user.
• •Human immunodeficiency virus (HIV) positive (testing not conducted).
• •Unable to correctly use oral MDI.
• •Taking any restricted medications prior to Screening without meeting washout.
• •Cannot adhere to permitted concomitant \& prohibited medications.
• •May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time of study.
• •Not be randomized into study more than once.
• •No person directly associated with administration of study may participate.
• •Previously participated in MF/F trial.
• •Increase in absolute volume of \>=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.
• •Asthma.
• •Blood eosinophil count greater than 0.57 x 10\^3/microliter (uL).
• •Lobectomy, pneumonectomy or lung volume reduction surgery.
• •Lung cancer.
• •Requires long-term administration of oxygen (\>15 hours per day).
• •A subject who experiences an exacerbation of COPD requiring medical
• •intervention within 4 weeks prior to randomization, beta-blocking agents, or
• •treatment with additional excluded medication (other than short-acting beta agonists (SABA)/short-acting
• •anticholinergic to be used as rescue medication).
• •alpha-1-antitrypsin deficiency.
• •Cataract extractions on both eyes.
• •A history and/or presence of intraocular pressure in either eye \>=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening:
• •nuclear opalescence (NO): \>=3.0,
• •nuclear color (NC): \>=3.0,
• •cortical cataract (C): \>=2.0,
• •posterior subcapsular (P): \>=0.5.