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

Mylan

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Formoterol; Drug: Revefenacin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03573817

0167

Details and patient eligibility

About

The primary objective of the study was 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 participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.

Enrollment: 122 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is a male or female subject 40 years of age or older.
• Participant is willing and able to provide signed and dated written informed consent.
• Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
• Participant must be willing and able to attend study visits according to the visit schedule and adhere to all study assessments/procedures.

Exclusion criteria

• Participant 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.
• Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics, short-acting beta-agonists and long-acting beta-agonists.
• Participant with clinically significant and uncontrolled hypertension, hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.
• Participant 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

Period 1: Revefenacin + Formoterol (Sequential)

Experimental group

Description:

Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.

Treatment:

Drug: Revefenacin

Drug: Formoterol

Period 2: Revefenacin + Formoterol (Combo Solution)

Experimental group

Description:

Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.

Treatment:

Drug: Revefenacin

Drug: Formoterol

Period 1: Placebo + Formoterol (Sequential)

Placebo Comparator group

Description:

Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.

Treatment:

Drug: Placebo

Drug: Formoterol

Period 2: Placebo + Formoterol (Combo Solution)

Placebo Comparator group

Description:

Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.

Treatment:

Drug: Placebo

Drug: Formoterol