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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573817
• Other study ID #: 0167
• Status: Completed
• Phase: Phase 3
• Start date: May 31, 2018
• Est. completion date: September 25, 2018

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Revefenacin
Revefenacin is administered via a nebulizer.
• Placebo
Placebo version of Revefenacin is administered via a nebulizer.
• Formoterol
Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Locations

Country	Name	City	State
United States	Theravance Biopharma Investigational Site	Columbus	Ohio
United States	Theravance Biopharma Investigational Site	Erie	Pennsylvania
United States	Theravance Biopharma Investigational Site	Gaffney	South Carolina
United States	Theravance Biopharma Investigational Site	Greenville	South Carolina
United States	Theravance Biopharma Investigational Site	Medford	Oregon
United States	Theravance Biopharma Investigational Site	Miami	Florida
United States	Theravance Biopharma Investigational Site	Monroe	North Carolina
United States	Theravance Biopharma Investigational Site	Orlando	Florida
United States	Theravance Biopharma Investigational Site	Saint Charles	Missouri
United States	Theravance Biopharma Investigational Site	Sarasota	Florida
United States	Theravance Biopharma Investigational Site	Spartanburg	South Carolina
United States	Theravance Biopharma Investigational Site	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event	An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.	Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Primary	Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event	A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: Death; Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe; Inpatient hospitalization or prolongation of existing hospitalization; Congenital anomaly in the offspring of a participant who received study drug; Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition; A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.	Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Primary	Number of Participants With Clinically Relevant Changes in Vital Sign Measurements	Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.	Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Primary	Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements	Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.	Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Primary	Number of Participants With Clinically Relevant Changes in Electrocardiogram Results	Clinically relevant changes identified based on change from baseline.	Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)