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NCT03573817 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Mylan.

Completed
Registry status
Phase 3
Development phase
122
Enrollment target

NCT03573817 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 122 participants.

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The verdict

NCT03573817, a Phase 3 study, has completed, sponsored by Mylan.

COMPLETED
Registry status
Phase 3
Development phase
122 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG Formoterol
  • DRUG Revefenacin

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2018-05-31
Est. Completion 2018-09-25
Phase Phase 3

Sponsor

Mylan

22 total trials

What the Registry Record Tells You About NCT03573817

The ClinicalTrials.gov registry entry for NCT03573817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03573817 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03573817 about?

NCT03573817 is a clinical study titled "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 seve...

What is the current status of trial NCT03573817?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2018-05-31. Estimated completion is 2018-09-25.

What interventions are being tested in trial NCT03573817?

The interventions under investigation include: Placebo (DRUG), Formoterol (DRUG), Revefenacin (DRUG).

Who is sponsoring clinical trial NCT03573817?

This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.