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

Last updated: February 22, 2022
Sponsor: Mylan Inc.
Overall Status: Completed

Phase

3

Condition

Lung Disease

Emphysema

Bronchiectasis

Treatment

N/A

Clinical Study ID

NCT03573817
0167
  • Ages > 40
  • All Genders

Study 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

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 cigaror pipe smoking history) of at least 10 pack-years.
  • Participant must be willing and able to attend study visits according to the visitschedule and adhere to all study assessments/procedures.

Exclusion

Exclusion Criteria:

  • Participant has a concurrent disease or condition that, in the opinion of theinvestigator, would interfere with study participation or confound the evaluation ofsafety, tolerability, or pharmacokinetics of the study drug.
  • Participant has a history of reactions or hypersensitivity to inhaled or nebulizedanticholinergics, 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 duringthe washout (if required) and treatment period and follow-up period of the study.

Study Design

Total Participants: 122
Study Start date:
May 31, 2018
Estimated Completion Date:
September 25, 2018

Connect with a study center

  • Theravance Biopharma Investigational Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Orlando, Florida 32825
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Tampa, Florida 33603
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Erie, Pennsylvania 16508
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Gaffney, South Carolina 29341
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Theravance Biopharma Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

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