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Completed

NCT Number: NCT03573817

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Theravance Biopharma Investigational Site, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revefenacin

Drug

Revefenacin is administered via a nebulizer.

Other names: TD-4208

Placebo

Drug

Placebo version of Revefenacin is administered via a nebulizer.

Formoterol

Drug

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

Primary outcomes

  1. Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event

    Time frame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

    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.

  2. Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event

    Time frame: Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

    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.

  3. Number of Participants With Clinically Relevant Changes in Vital Sign Measurements

    Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

    Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.

  4. Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements

    Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

    Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.

  5. Number of Participants With Clinically Relevant Changes in Electrocardiogram Results

    Time frame: Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

    Clinically relevant changes identified based on change from baseline.

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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