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COMPLETED Phase 3

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

NCT02276222 · View on ClinicalTrials.gov ↗

Study Summary

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Interventions

  • DRUG SUN-101 50 mcg BID eFlow (CS) nebulizer
  • DRUG Spiriva® 18 mcg QD Handihaler

Study Locations (20)

Florida

  • Tampa Bay Clinical Research Center — Brandon
  • Clinical Research of West Florida — Clearwater
  • Avail Clinical Research, llC — DeLand
  • The Community Research of South Florida — Hialeah
  • AppleMed Research, Inc — Miami
  • Research Institute of South Florida, Inc — Miami
  • Clinical Trials of Florida, LLC — Miami
  • Florida Institute For Clinical Research, LLC — Orlando

California

  • Allianz Research Institute, Inc. — Fountain Valley
  • Research Center of Fresno, Inc. — Fresno
  • California Research Medical Group, lnc. — Fullerton
  • Southern California Institute For Respiratory Diseases, Inc. — Los Angeles
  • Integrated Research Group, Inc — Riverside
  • Institute of Healthcare Assessments Inc. — San Diego

Alabama

  • SEC Lung LLC — Andalusia
  • Achieve Clinical Research LLC — Birmingham
  • Jasper Summit Research LLC — Jasper

Arizona

  • Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC — Chandler
  • Desert Sun Clinical Research LLC — Tucson

Connecticut

  • Waterbury Pulmonary Associates, LLC — Waterbury

Trial Details

FieldValue
Enrollment Target 1,087 participants
Start Date 2014-10
Est. Completion 2016-02
Phase Phase 3

Sponsor

Sunovion Respiratory Development

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02276222

The ClinicalTrials.gov registry entry for NCT02276222 describes a study currently listed as completed. It is categorized as Phase 3, 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 1,087 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sunovion Respiratory Development, which has 2 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 (COPD) appearing as the primary indexed condition, and to 2 interventions — of which SUN-101 50 mcg BID eFlow (CS) nebulizer 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: NCT02276222 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT02276222 about?

NCT02276222 is a clinical study titled "A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD". This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

What is the current status of trial NCT02276222?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,087 participants. The study started on 2014-10. Estimated completion is 2016-02.

What conditions does trial NCT02276222 study?

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

What interventions are being tested in trial NCT02276222?

The interventions under investigation include: SUN-101 50 mcg BID eFlow (CS) nebulizer (DRUG), Spiriva® 18 mcg QD Handihaler (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02276222?

This trial is sponsored by Sunovion Respiratory Development, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02276222 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. 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