NCT03573817|CompletedPhase 3ResultsFDA Drug

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

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

Mylan Inc.ClinicalTrials.gov

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1 other identifier

0167

Study Type

interventional

Target

122

Locations

1 country

Sites

Timeline

RegisteredJun 2018

StartedMay 2018

CompletionSep 2018

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

122

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started May 2018

Shorter than P25 for phase_3

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

May 24, 2018

Completed

7 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed

29 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 18, 2019

Completed

Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

May 24, 2018

Results QC Date

November 27, 2019

Last Update Submit

February 22, 2022

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary DiseasePulmonary FunctionCOPDPerformist

Outcome Measures

Primary Outcomes (5)

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)
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)
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)
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)
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)

Study Arms (4)

Period 1: Revefenacin + Formoterol (Sequential)

EXPERIMENTAL

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

Drug: RevefenacinDrug: Formoterol

Period 2: Revefenacin + Formoterol (Combo Solution)

EXPERIMENTAL

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.

Drug: RevefenacinDrug: Formoterol

Period 1: Placebo + Formoterol (Sequential)

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Formoterol

Period 2: Placebo + Formoterol (Combo Solution)

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Formoterol

Interventions

RevefenacinDRUG

Revefenacin is administered via a nebulizer.

Also known as: TD-4208

Period 1: Revefenacin + Formoterol (Sequential)Period 2: Revefenacin + Formoterol (Combo Solution)

PlaceboDRUG

Placebo version of Revefenacin is administered via a nebulizer.

Period 1: Placebo + Formoterol (Sequential)Period 2: Placebo + Formoterol (Combo Solution)

FormoterolDRUG

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Period 1: Placebo + Formoterol (Sequential)Period 1: Revefenacin + Formoterol (Sequential)Period 2: Placebo + Formoterol (Combo Solution)Period 2: Revefenacin + Formoterol (Combo Solution)

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.