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RECRUITING Phase 2

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

NCT07016412 · View on ClinicalTrials.gov ↗

Study Summary

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Interventions

  • DRUG Placebo
  • DRUG Ensifentrine 3 mg
  • DRUG Glycopyrrolate 21.25 mcg
  • DRUG Glycopyrrolate 42.5 mcg

Study Locations (20)

Florida

  • Clinical Research of West Florida Inc — Clearwater
  • Fleming Island Center For Clinical Research — Fleming Island
  • Florida Institute For Clinical Research LLC — Orlando
  • Ormond Beach Clinical Research — Ormond Beach
  • Progressive Medical Research — Port Orange
  • Clinical Research of West Florida Inc - Tampa — Tampa

California

  • Downtown LA Research Center Inc - ClinEdge — Los Angeles
  • California Medical Research Associates, Inc. — Northridge
  • Northern California Research Corp — Sacramento

Missouri

  • Midwest Chest Consultants PC — Saint Charles
  • Midwest Clinical Research LLC — St Louis
  • The Clinical Research Center LLC - CRN — St Louis

Georgia

  • Centricity Research Columbus Georgia — Columbus
  • Southeast Lung Associates Research — Rincon

Indiana

  • ASHA Clinical Research - Hammond — Hammond
  • Velocity Clinical Research - Valparaiso — Valparaiso

Alabama

  • SEC Clinical Research, LLC — Dothan

Arizona

  • Elite Clinical Studies, LLC — Phoenix

Maryland

  • Velocity Clinical Research — Rockville

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2025-07-31
Est. Completion 2026-04-29
Phase Phase 2

Sponsor

Verona Pharma

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07016412

The ClinicalTrials.gov registry entry for NCT07016412 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Verona Pharma, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07016412 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07016412 about?

NCT07016412 is a clinical study titled "A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD". This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects wit...

What is the current status of trial NCT07016412?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 480 participants. The study started on 2025-07-31. Estimated completion is 2026-04-29.

What conditions does trial NCT07016412 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07016412?

The interventions under investigation include: Placebo (DRUG), Ensifentrine 3 mg (DRUG), Glycopyrrolate 21.25 mcg (DRUG), Glycopyrrolate 42.5 mcg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07016412?

This trial is sponsored by Verona Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07016412 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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