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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573817
Recruitment Status : Completed
First Posted : June 29, 2018
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Theravance Biopharma

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Revefenacin Drug: Placebo Drug: Formoterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Period 1: Revefenacin + Formoterol (Sequential)
Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.
Drug: Revefenacin
Revefenacin is administered via a nebulizer.
Other Name: TD-4208

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

Experimental: Period 2: Revefenacin + Formoterol (Combo Solution)
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: Revefenacin
Revefenacin is administered via a nebulizer.
Other Name: TD-4208

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

Placebo Comparator: Period 1: Placebo + Formoterol (Sequential)
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: Placebo
Placebo version of Revefenacin is administered via a nebulizer.

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

Placebo Comparator: Period 2: Placebo + Formoterol (Combo Solution)
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: Placebo
Placebo version of Revefenacin is administered via a nebulizer.

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573817


Locations
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United States, Florida
Theravance Biopharma Investigational Site
Miami, Florida, United States, 33155
Theravance Biopharma Investigational Site
Orlando, Florida, United States, 32825
Theravance Biopharma Investigational Site
Sarasota, Florida, United States, 34239
Theravance Biopharma Investigational Site
Tampa, Florida, United States, 33603
United States, Missouri
Theravance Biopharma Investigational Site
Saint Charles, Missouri, United States, 63301
United States, North Carolina
Theravance Biopharma Investigational Site
Monroe, North Carolina, United States, 28112
United States, Ohio
Theravance Biopharma Investigational Site
Columbus, Ohio, United States, 43213
United States, Oregon
Theravance Biopharma Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Theravance Biopharma Investigational Site
Erie, Pennsylvania, United States, 16508
United States, South Carolina
Theravance Biopharma Investigational Site
Gaffney, South Carolina, United States, 29341
Theravance Biopharma Investigational Site
Greenville, South Carolina, United States, 29615
Theravance Biopharma Investigational Site
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Theravance Biopharma
Mylan Inc.
Investigators
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Study Director: Medical Monitor Theravance Biopharma
  Study Documents (Full-Text)

Documents provided by Theravance Biopharma:
Study Protocol  [PDF] April 16, 2018
Statistical Analysis Plan  [PDF] October 1, 2018

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03573817    
Other Study ID Numbers: 0167
First Posted: June 29, 2018    Key Record Dates
Results First Posted: December 18, 2019
Last Update Posted: December 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
Chronic Obstructive Pulmonary Disease
Pulmonary Function
COPD
Performist
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action