A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Subjects With COPD

The primary objective of the study is to characterize the safety and tolerability of
once-daily revefenacin inhalation solution when dosed sequentially with twice-daily
formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of
patients with moderate-to-very severe COPD over 21 days.

The secondary objective of this study is to characterize the safety and tolerability of
dosing a mixture of revefenacin inhalation solution and formoterol compared to dosing a
mixture of placebo and formoterol in a population of patients with moderate-to-very severe
COPD over 21 days.

The study intends to enroll approximately 120 subjects across 12 sites in the United States.

Inclusion Criteria:

- Subject is a male or female subject 40 years of age or older.

- Subject is willing and able to provide signed and dated written informed consent.

- Subject has a current or past cigarette smoking history (or equivalent for cigar or
pipe smoking history) of at least 10 pack-years.

- Subject must be willing and able to attend study visits according to the visit
schedule and adhere to all study assessments/procedures.

Exclusion Criteria:

- Subject has a concurrent disease or condition that, in the opinion of the
investigator, would interfere with study participation or confound the evaluation of
safety, tolerability, or pharmacokinetics of the study drug.

- Subject has a history of reactions or hypersensitivity to inhaled or nebulized
anticholinergics, short-acting beta-agonists and long-acting beta-agonists.

- Subjects with clinically significant and uncontrolled hypertension,
hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.

- Subject is unwilling or unable to stop the use of prohibited medications during the
washout (if required) and treatment period and follow-up period of the study.