Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

NCT02766608 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Interventions

  • DRUG BFF MDI 320/9.6 μg
  • DRUG BFF MDI 160/9.6 μg
  • DRUG FF MDI 9.6 μg
  • DRUG BD MDI 320 μg
  • DRUG Symbicort® TBH 400/12 μg BID

Study Locations (20)

California

  • Research Site — Anaheim
  • Research Site — Gold River
  • Research Site — Palm Springs
  • Research Site — Sacramento
  • Research Site — San Diego

Florida

  • Research Site — Clearwater
  • Research Site — Clearwater
  • Research Site — DeLand
  • Research Site — Hialeah
  • Research Site — Miami

Alabama

  • Research Site — Athens
  • Research Site — Birmingham
  • Research Site — Dothan

Arizona

  • Research Site — Phoenix
  • Research Site — Phoenix
  • Research Site — Tucson

Colorado

  • Research Site — Boulder
  • Research Site — Colorado Springs
  • Research Site — Littleton

Connecticut

  • Research Site — Hamden

Trial Details

FieldValue
Enrollment Target 2,389 participants
Start Date 2016-05-31
Est. Completion 2017-12-01
Phase Phase 3

Sponsor

Pearl Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02766608

The ClinicalTrials.gov registry entry for NCT02766608 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 2,389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 3 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 Disorder appearing as the primary indexed condition, and to 5 interventions — of which BFF MDI 320/9.6 μg 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: NCT02766608 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, 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 NCT02766608 about?

NCT02766608 is a clinical study titled "Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD". This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

What is the current status of trial NCT02766608?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,389 participants. The study started on 2016-05-31. Estimated completion is 2017-12-01.

What conditions does trial NCT02766608 study?

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

What interventions are being tested in trial NCT02766608?

The interventions under investigation include: BFF MDI 320/9.6 μg (DRUG), BFF MDI 160/9.6 μg (DRUG), FF MDI 9.6 μg (DRUG), BD MDI 320 μg (DRUG), Symbicort® TBH 400/12 μg BID (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02766608?

This trial is sponsored by Pearl Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02766608 being conducted?

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