Clinical trial NCT03573817: A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Official title: A Phase 3b, 42-day, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized Revefenacin and Nebulized Formoterol Fumarate (PERFOROMIST®) Administered in Sequence and as a Combined Solution in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
Pulmonary Function
COPD
Performist
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2018-06-29
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
timeFrame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
measure: Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
timeFrame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
measure: Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
timeFrame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
measure: Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
timeFrame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
measure: Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
timeFrame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Orlando
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Tampa
country: United States
facility: Theravance Biopharma Investigational Site
state: Florida
city: Saint Charles
country: United States
facility: Theravance Biopharma Investigational Site
state: Missouri
city: Monroe
country: United States
facility: Theravance Biopharma Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Theravance Biopharma Investigational Site
state: Ohio
city: Medford
country: United States
facility: Theravance Biopharma Investigational Site
state: Oregon
city: Erie
country: United States
facility: Theravance Biopharma Investigational Site
state: Pennsylvania
city: Gaffney
country: United States
facility: Theravance Biopharma Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Theravance Biopharma Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Theravance Biopharma Investigational Site
state: South Carolina
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: